Director, Quality Assurance Resume Sample
Lola Hagenes
86062 VonRueden Creek,
Detroit,
MI
+1 (555) 248 4713
Work Experience
Director, Quality Assurance
05/2017
-
PRESENT
Houston, TX
- Typically exercises direct accountability for programs (including related sub-projects) with 50 team members or more
- Determines and establishes the appropriate program organizational and work breakdown structures (e.g. projects, work streams) to accomplish program outcomes. Ensures program milestones and schedule accurately reflects the delivery commitments of subsidiary projects. Ensures an overall integrated delivery plan is developed, maintained and communicated
- Support the Company’s project teams and assist with project scheduling to assure that timelines and deadlines are met in the most efficient and economical manner
- Hire, manage, support and develop/train QA staff and secure sufficient resources to support the company’s goals and objectives
- Meet with production management on regular basis and support goals outlined in the company’s operating plan
- Define, communicate and enforce quality policies with particular emphasis on compliance to the company’s Quality System and external regulatory standards
- Develop Avanir Internal Audit Program and overall process including reviewing, improving, and updating current GxP Audit SOP’s. Conduct Avanir Internal Audit every year for each of the critical GxP functions, processes, and systems
Director Quality Assurance
01/2014
-
03/2017
Dallas, TX
- Prepares and process quality reports by collecting, analyzing, and summarizing information and trends including KPI’s and SLA management
- Detail-oriented review of weekly Service Level Agreement (SLA) metrics to identify trends with SLA’s and identify , what corrective actions need to be taken to improve going forward
- Manages and implements Lone Star College’s (LSC) policies and procedures to ensure the accurate, timely and ethical compliance of the Title IV program funds according to federal and/or state regulations
- Monitors the administration of all federal, state and institutional financial aid programs including the review of these programs through federal, state, and institutional audits
- Performs routine audits on active and inactive student files to ensure compliance with Title IV regulations
- Creates an annual audit plan for state and federal programs
- Makes periodic visits to college campuses to ascertain training needs and any regulatory compliance deficiencies
- Assists the Executive and System Directors in developing communication pertinent to LSC’s financial aid programs through the design of calendars, flyers, posters, brochures, and articles
Ntess Director Quality Assurance
08/2008
-
08/2013
Houston, TX
- Assists Program Operations by ensuring accurate completion of verification and documentation of students’ status
- Conducts personnel evaluations and assists staff members in planning professional and developmental experiences
- Manages budget development through program, staffing and needs assessment
- Participate in state, college and system committees to ensure efficiency of the delivery of financial aid
- Serve as a subject matter expert to the company on QA related issues by communicating proactively and effectively with cross-functions at all level
- Develop, implement, execute, and maintain, and communicate the Quality Assurance Procedures and Standards in accordance to applicable laws and regulations
- Execute and manage quality assurance procedures in ensuring continuous compliance with all applicable internal and external regulations, standards, policies, and procedures related to the quality, regulatory status, and performance of company operations, processes and products
- Maintain a world-class quality management system by directing, and providing oversight and input for CMO’s into the relevant quality systems and standards including: batch release and control; change control; quality assurance procedures and standards; product complaints and recalls; quality system reporting; investigations and CAPAs; quality agreements
- Actively engaged and participate as part of inspection readiness activities
Education
Southwest Minnesota State University
2003 - 2008
Bachelor's Degree in Computer Science
Professional Skills
- Strong leadership, partner management, influencing skills with strong people management skills
- Detail oriented with strong managerial, organization, leadership and analytical skills combined with excellent people skills and cultural awareness
- Strong experience in a leadership role with exceptional leadership skills; demonstrates a passion for guiding and developing others; seeks feedback
- Excellent interpersonal, verbal and written communication skills, including experience in making presentations at conferences, meetings and training sessions
- Managerial experience with strong training and coaching skills
- Excellent verbal and written skills with the power to persuade and drive continuous improvement while maintaining / building strong partner relationships
- + Strong leadership, communication, and business partnering skills along with excellent negotiation and problem resolution
How to write Director, Quality Assurance Resume
Director, Quality Assurance role is responsible for leadership, technical, negotiation, business, analytical, advanced, development, organizational, interpersonal, reporting.
To write great resume for director, quality assurance job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Director, Quality Assurance Resume
The section contact information is important in your director, quality assurance resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Director, Quality Assurance Resume
The section work experience is an essential part of your director, quality assurance resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous director, quality assurance responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular director, quality assurance position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Director, Quality Assurance resume experience can include:
- Solid experience with effectively managing FDA and other regulatory agency inspections, working with regulators, and vendor audits essential
- Strong technical skills, both functional and non-functional testing, manual and automation
- Exceptional change management skills with a strong track record of building employee engagement
- Prior food industry experience, prior successful management of processes and personnel
- Advanced skills in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities
- Managing all validation activities, including validation strategy and approval of protocols and reports
Education on a Director, Quality Assurance Resume
Make sure to make education a priority on your director, quality assurance resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your director, quality assurance experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Director, Quality Assurance Resume
When listing skills on your director, quality assurance resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical director, quality assurance skills:
- Demonstrate advanced leadership skills with focus on strategy and continuous improvement skills
- Effective writing skills, including proposals, reports, procedures, forms etc
- Strong computer, technical skills, and data analysis and reporting using, Microsoft Excel, Access, Word, PowerPoint and Minitab
- Specific health plan functional/operations experience and prior testing experience required
- Excellent organizational, analytical, data review and report writing skills
- Critically examine and audit technical procedures for both food safety and quality. Preference for excellent problems solving skills
List of Typical Experience For a Director, Quality Assurance Resume
1
Experience For Director Quality Assurance Resume
- Strong written and oral communications skills and strong Change management skills
- Systematic with good problem solving, statistical analyst and project management skills
- Effectively prioritize and manage multiple components of Transformation at the same time
- Very strong communication negotiation and presentation skills
- Excellent communication skills: oral, written, and presentation
- Superior technical writing, problem solving and presentation skills are required
- Effectively manage the QA&C resources on the account to ensure successful delivery of support to Sodexo Operations
- Strong automated test experience
2
Experience For Senior Director, Quality Assurance Resume
- Experience as a QA engineer or 3+ years of hands-on experience as a software developer in test
- Lead a team of 40+ employees effectively
- Experience with Quality Systems and direct experience with FDA audits for pharmaceutical products or related medical products
- Experience with FDA is a strong preference
- Design, implement and resource an appropriate quality training system including monitoring effectiveness
- Drives prioritization and decision making based on EmblemHealth’s strategic objectives, corporate values, and program guiding principles
- Utilizes testing knowledge and experience to assess, and advises on the practicality of testing process alternatives
- Drives adoption of modern testing approaches and techniques to both ensure excellent quality standards while delivering with velocity
3
Experience For Ntess Director Quality Assurance Resume
- + Experience leading management operating systems
- Execute and operate within approved operating budget
- Develop Quality Management system to achieve substantial improvements in the customer experience while optimizing costs and operational requirements
- + Validates all engineering change notices
- Partners with Customer & consumer complaint department to oversee complaint handling, provide metrics and ensure timely and effective closure of CAPAs
4
Experience For Director, Quality Assurance Engineering Resume
- Interface with supplier and customer quality representatives concerning problems with quality and assure that effective correction action is implemented
- As a leader of Quality teams. Experience managing global distributed teams
- Experience with the concepts of “black box” and “gray box” testing
- Is comfortable and experienced with regulatory agency inspections - including, but not limited to, FDA
- Experienced in handling FDA inspections
- Experience in working within an FDA regulated environment for medical device
5
Experience For Director Quality Assurance & Compliance Resume
- Experience utilizing waterfall, incremental and agile methodologies
- Skilled in reliability and maintainability programs in accordance with governing standards and specifications
- Experience in system, security, functional, automation and performance testing
- Relevant claims handling experience in addition to proficiency in MS Office applications, and related claims and business software
- Demonstrate competence in quality assurance and management, emphasizing continuous improvement
- Solid understanding of software development cycles, particularly for microservice-based applications
- Strong knowledge of cGMP, GLP requirements, PTC guidelines and ISO 17205
6
Experience For Senior Director Quality Assurance Resume
- Oversee the approval of exception reports, CAPAs, effectiveness checks, and initial impact assessments in the TrackWise system
- Ensures that the site’s implementation of Quality Systems and goals are integrated in a cost effective and productive manner
- Experience with Continuous Integration and Continuous Deployment (CICD)
- Experienced in mobile and web test automation
- Proven ability to influence and lead an organization through a cultural change
7
Experience For Director, Quality Assurance GxP Compliance Resume
- Maintain and enhance an effective Quality Management System (QMS)
- Ensure that all required validation activities are completed
- Extensive experience in planning, coordination and implementation of multiple concurrent projects
- BS/BA in Engineering or other scientific, technical, or business discipline or equivalent combination of education and experience
- Strong influencer and champion of change
- Pharmaceutical industry experience
- Related work experience in higher education; at least 3 years in a management or director level position
- Experience in the pharmaceutical/ biotechnology industry
- Relevant experience in quality assurance in software and/or application development
8
Experience For Director, Quality Assurance Operations Resume
- Quality Assurance/Regulatory Assurance experience
- Experience in the medical device or pharmaceutical industry
- Hands-on experience with FDA, CFDA, QSR, ISO, MDD and/or other international quality systems requirements
- Experience in Quality Control/Quality Assurance
- Experience in QA Management or a related field
- QA Management experience across multiple projects, off-shore and in-house
- Experience with a continuous improvement methodology and related analysis tools, e.g. Six Sigma, Lean or PPI, Black Belt or Lean certification
- Experience with MasterControl electronic Document Management System
9
Experience For Director, Quality Assurance & Food Safety Resume
- Skilled problem solver who works with a sense of urgency and is results oriented
- Experience as a Software Quality Assurance professional
- Experience with full software development life cycles and process improvement methodologies
- Demonstrated ability to successfully manage multiple teams and multiple projects
- Experience with Microsoft based applications and ability to learn internal computer systems
- Extensive knowledge of current Good Laboratory Practices (GLP) and pharmaceutical research and development processes in regulated environments
- Senior Management experience in Quality Assurance / Regulatory Compliance
- + Experience utilizing risk management as a proactive management practice to prevent quality issues
- + Experience leading change or transformation initiatives
10
Experience For Executive Director, Quality Assurance Resume
- + Experience establishing operational metrics and key indicators for process control, communication, and performance improvement
- Experience in HIPAA or other secure environments is highly desirable
- Previous supervisory/management experience is required
- Business acumen to understand the investments and impact to drive improvements in the customer experience
- Experience in a leadership and management position for multiple QA teams and multiple enterprise software products
- Strong food safety background and knowledge of regulatory requirements
- Strong knowledge of food safety and quality. Ability to function as a food safety resource when needed
- Strong attention to detail and ability to work independently in a fast-paced environment
List of Typical Skills For a Director, Quality Assurance Resume
1
Skills For Director Quality Assurance Resume
- Demonstrated Strong relationship building skills (with Partners, teams and the exec level)
- Strong project management skills, strategic mindset and demonstrated business acumen
- Experience with application of FDA current Good Manufacturing Practices with a proven track record of business performance improvement
- Excellent critical thinking and project management skills
- + Excellent communication skills (written, verbal, public speaking) are required
- Effective teamwork and project management skills
- Effective and persuasive communicator with the ability to effectively convey ideas to all levels of management
- Strong communication skills (English written, verbal and presentations)
2
Skills For Senior Director, Quality Assurance Resume
- Excellent management skills; able to lead, direct, empower, support and encourage the development of team members
- Superior project management, prioritization, organization and planning skills
- Excellent communication, analytical, leadership and inter-personal skills
- Working knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
- Previous experience in building and leading a strong Manufacturing Quality Assurance team
- Experience managing quality engineering functions within both a device and drug/device manufacturing environment strongly
3
Skills For Ntess Director Quality Assurance Resume
- Demonstrated experience in leading and driving high performing teams
- Prior experience working with /overseeing vendors required
- Proven experience supporting the buildout and qualification of a manufacturing facility
- Delegate effectively, focusing on results, allowing others to learn and grow in a supportive environment
- A strong leader with experience in implementing and shaping a company’s QA processes and strategies
- Strong understanding of and experience with Performance Testing Frameworks and architecture
- Demonstrated expertise in implementing successful process and continuous improvement efforts, yielding increased effectiveness and efficiency
- Proven effectiveness in allocating and managing resources, both material and financial
4
Skills For Director, Quality Assurance Engineering Resume
- Utilizes advanced leadership and collaborative skills in interacting with stakeholders and control/business/affiliate partners
- Effectively lead and manage crisis situations, providing direction and solutions
- Experience or greater in Quality Management and a Bachelors in Engineering, or related field or equivalent experience required
- Strong understanding of and experience with Automation Frameworks and architecture
- Expert knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
5
Skills For Director Quality Assurance & Compliance Resume
- Effectively manage numerous projects at one time
- Ensure effective and efficient systems are in place to appropriately measure and improve effectiveness of areas of responsibility
- Coordination and communication skills necessary for the highest level programs
- Skills in human relations techniques, both internally within division, company, and externally with customers
- Technical skills with mechanical and electrical comprehension
- Effectively work in a matrixed environment
6
Skills For Senior Director Quality Assurance Resume
- Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations
- Experience and demonstrated success with implementing quality systems and process improvements utilizing lean manufacturing and six sigma techniques
- Strong experience and direct responsibility for management of Quality Assurance programs
- Effectively communicate and flow down objectives to all employees
- Working knowledge and experience in developing training programs, working with alchemy and developing in house seminars and training modules
- Developing departmental plans, including business and/or organization priorities with decisions being guided by the strategy and direction of the department
- Demonstrating strong portfolio management and quality engineering knowledge and is able to guide both junior and senior team members
- Applying strong analytical thinking to establish value add metrics and measures
7
Skills For Director, Quality Assurance GxP Compliance Resume
- Working knowledge and quality oversight experience in Safety, Pharmacovigilance and Medical Affairs disciplines also required
- Ensuring team has clear priorities and adequate resources
- Experience managing end to end testing strategy including working with the business on business acceptance
- Progressive management experience in manufacturing environment, including background in engineering, quality and manufacturing
- General experience with APIs and knowledge of automated testing, including unit testing, integration
- Experience in automated testing including unit and functional testing within the force.com platform as
8
Skills For Director, Quality Assurance Operations Resume
- Experience with quality assurance practices and tools (including requirements traceability, automated testing tools, defect tracking)
- Experience assessing food safety of formulas and ensuring finished product and raw material specifications are capable of delivering safe food
- Experience in designing and implementing quality systems
- Provision of management support to team, including prioritization of tasks, evaluation and monitoring of quality and timeliness of work performed
- Strong understanding of common aseptic manufacturing processes used in the manufacture of small molecules
- Experience with QA practices and audit approaches applicable to non-manufacturing organizations, including software development
- Preference to experience presenting and communicating scientific data to audiences
- Extensive experience in reading and writing SQL scripts and queries
9
Skills For Director, Quality Assurance & Food Safety Resume
- Extensive experience with writing Test Cases and Test Scripts, including creation of test data
- Enterprise software product quality assurance experience including test planning, implementation and execution
- Previous experience managing bug defect solutions & driving the creation of test plans
- Administers effective training and on-the-job training of Quality Assurance personnel
- Experience in managing a Quality Assurance and/or Testing team
- Experience creating and managing organization budgets
10
Skills For Executive Director, Quality Assurance Resume
- Good understanding of the pharmaceutical industry and regulations applicable for a contract testing laboratory
- Has had experience working in a manufacturing plant
- Deep experience with Quality and Engineering practices (Continuous Integration, Continuous Delivery, Test Driven Development, test automation, pairing)
- Experience building massive automation frameworks for customer facing and backend systems
- Financial acumen with experience managing own budget
- Experience in using scrum methodology and tools such as git, Jenkins and Github
- Proven ability with Word Processing and other Microsoft Office applications
- Strong problem solving ability and is results driven
- Remains calm and self-controlled under pressure. Builds excellent working teams
List of Typical Responsibilities For a Director, Quality Assurance Resume
1
Responsibilities For Director Quality Assurance Resume
- Oversee and provide guidance to VF Asia in the Timberland vendor qualification process. Ensure that the process is representative of Timberland’s Quality and Product Safety requirements
- Establish and direct, in conjunction with RD&D, a Timberland new style design conformance process. Ensure that new styles conform to Timberland’s Quality requirements. Drive root cause and corrective action for non-conforming styles. Identify changes to standards and processes that result in a stronger process
- Demonstrated effective change management skills in strong cultural environments
- Uccessful and progressive experience in a medium or large size company, 5+ in management, preferably in the soft goods and hard goods industry
- Demonstrated ability to work constructively, collaboratively, and effectively at all levels across functions as well as with external customers
- Previous engineering and/or quality assurance experience, with managerial experience
- Experience managing personnel - or equivalent training and/or experience
- Experience with Phases I thru IV (particularly Phase III); experience with regulatory approval, NDAs and MAAs
2
Responsibilities For Senior Director, Quality Assurance Resume
- Drive continuous improvement through adopting and improving processes, tools, skills, and infrastructure
- Successfully lead teams to enable them to effectively perform
- Experience developing and/or testing a broad range of application types including consumer facing, web-based, API, batch, headless and thick client
- Review and approve IQ/OQ/PQ and validation protocols and reports, as applicable, for all manufacturing, testing and packaging activities
- Experience in testing other connected devices such as 10’ devices (App TV’s, DVD players, Gaming Consoles etc.)
- A good understanding / familiarity with GLPs and GCPs is essential
- Quality or regulatory experience working in an ISO and/or FDA cGMP environment
3
Responsibilities For Ntess Director Quality Assurance Resume
- Experience with regulations (ie.21.CFR.820) & interfacing with regulatory bodies
- Effective developer of internal talent, succession-planning and career development of staff
- Experience working with agile methods in multiple organizations
- Comfortable balancing the priorities of both business and technology
- Expert Agile, Spiral, and Waterfall SDLC experience
- Quality assurance experience in medical device, pharma or life sciences global environment
- Analyzes customers’ product specifications to establish efficient, cost-effective requirements for ease of manufacture and reproducibility
- Experience managing IT systems. Knowledge of QMS, LIMS database structures
4
Responsibilities For Director, Quality Assurance Engineering Resume
- Oversees CAPA System(s) to ensure robust execution from discovery through Corrective Action(s), including Effectiveness checks
- Evaluates the effectiveness of corrective actions to ensure preventative measures are in place to avoid repeat occurrences
- Oversee compliance-critical functions including change control, validation and compliance and quality improvement projects
- Analyze customers' product specifications to establish efficient, cost-effective requirements for ease of distribution and responsibility
- Promotes and develops effective relationships with suppliers
- Experienced quality leader or quality project manager of cross-functional teams
5
Responsibilities For Director Quality Assurance & Compliance Resume
- Demonstrate advanced ability to evaluate and apply compliance requirements/ guidelines to complex situations
- Implement appropriate and effective quality systems
- Prioritize and execute multiple tasks, define problems, and resolve issues with limited supervision from senior management
- Several years of experience in a QA department in a related industry
- Past supervisory experience; and
- Experience overseeing and directing the development of new test frameworks and applications to ensure the implementation of manual and automated test solutions
- Demonstrated ability to lead and manage medium and large size QA automation teams successfully
- Develop core metrics to measure the customer experience, product quality and operational performance. Lead initiatives that achieve substantial improvements
6
Responsibilities For Senior Director Quality Assurance Resume
- Lead initiatives to improve complicated processes and organizational change required to improve the customer experience
- Strong background in reliability and quality of electronic products and assemblies
- Managing large, complex releases, resource deployments, capacity utilization and succession planning across the testing organization
- Formulating and executing on strategic testing initiatives that meet business and IT challenges
- Driving inspection readiness activities for the customer, including contributing to mock inspections by/of the customer
- Driving results across the portfolio of projects while meeting cost, efficiency and quality targets
- Understanding business needs and collaborating with development leadership to construct appropriate test solutions
- Overseeing overall product quality and testing for the Accessories division and support for all products distributed through the AOBSC
- Working knowledge of QA methodologies, SPC, Process Mapping, FMEA, Control Plans, etc
7
Responsibilities For Director, Quality Assurance GxP Compliance Resume
- Understanding of nested or relational data models and how to generate large mock data sets for testing
- Establishing and delivering on departmental objectives
- Devising test data management strategies across all test environments
- Ensuring that the supplier and subcontractor audits are performed and reported as scheduled
- Ensuring that there is a self-inspection program in place which is communicated to Operations to meet the requirements of established SOPs
- Understanding of technologies used for consumer websites especially around test automation (Ruby/Cucumber) and continuous integration (Jenkins)
- Working knowledge of ISO 9001 Quality Management Systems
- Understanding in all phases of metrology, inspection, and test methods
- Understanding of the integrated student services model
8
Responsibilities For Director, Quality Assurance Operations Resume
- Understanding of computerized information systems (preferably Oracle/PeopleSoft Campus Solutions, Financial Aid)
- Understanding of FDA, USDA and State Food Safety/Quality regulations
- Hold direct responsibility for managing and coordinating all quality functions on the manufacturing/packaging floor
- Interface with the IT Streaming Operational Support teams regarding new software releases, training, and trouble-shooting production problems
- Involvement in hiring, mentoring, management and development of high performing teams
- Able to work at many levels, including serving as a SQA lead and working with the leads of other disciplines to increase the SQA impact on the end product
- Influences business and technology QA/testing decisions to ensure that Transformation is maintaining currency with leading industry practices
- Business partnering and thought leadership across site functions and incorporating business acumen into decision making, recommendations and proposals
9
Responsibilities For Director, Quality Assurance & Food Safety Resume
- Oversee the testing of subsystems critical to providing streaming content delivered over Internet Protocol
- Ensure the required initial and continuing training is carried out and adapted according to need
- Responsible for ensuring the environmental monitoring and control of the manufacturing environment and plant hygiene
- Understand and analyze issues involving food manufacturing, natural sciences, mathematics (including statistics), technical and legal documents
- + Develops and maintains a site quality index, using statistical control programs, using predictive measures to prevent potential quality problems
- + Implement a lessons-learned system, including tracking of corrective and preventive actions; integrate findings with CAS
- Create and manage strategic plans, goal setting, scorecarding and metrics
- Responsible for ensuring that all drug products are compounding in accordance with PharMEDium’s quality requirements and in compliance with the cGMPs
- Specialized training and certification related to QA systems and practices applied to a non-manufacturing organization
10
Responsibilities For Executive Director, Quality Assurance Resume
- Objectively analying competitive products and technologies and making appropriate suggestions to influence direction with senior stakeholders
- Assist Quality Control personnel in reviewing and updating department standards
- Coordinate quality assurance efforts by encouraging a teamwork approach with Operations, Research and Development, Regulatory, Marketing and Sales
- Manage vendor quality by executing a vendor quality management program including quality agreements and periodic assessment of vendor performance metrics
- Ensures that plant QA are running efficiently while maintaining a safe workplace. Work with QA Managers on optimization of time/space/resources
- Provide marketing support in areas of proposal generation, technical marketing, and implementation of specialized programs
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