Senior Quality Systems Engineer Resume Sample
Jerome Balistreri
4311 Isom Lodge,
Dallas,
TX
+1 (555) 560 2902
Work Experience
Senior Quality Systems Engineer
09/2016
-
PRESENT
Boston, MA
- Ensures compliance of the Corrective Action and Preventative Action system
- Leads quality projects with cross functional teams
- Maintains quality records on product testing, nonconformance, project outcomes, and stakeholder input filed in an accurate and timely manner
- Coordinates change control documentation and approval process
- Makes proposals and assists in the development of corrective and preventative action plans and monitors implementation
- Follows up on closure of corrective and preventive actions
- Provides quality support for technology transfer and improvement of existing manufacturing processes
Senior Quality Systems Engineer
04/2010
-
03/2016
Philadelphia, PA
- Develops and conducts Effectiveness Monitoring actions
- Conducts investigations, collects data, analyzes trends and prepares reports for assigned quality processes. Has thorough understanding of process criteria and regulations and business impact of decisions and actions
- Assesses current quality systems and recommends improvements in order to enhance quality and reduce cycle time
- Prepares for and facilitates audits and inspections
- Assists in the development, implementation and review of standard operating procedures
- Maintain current knowledge of the FDA regulations (frequent reading of the trade press/emails, FDA news bulletins, attending job-related webinars, or outside courses when appropriate); consider innovative solutions to meet changing regulatory compliance goals
- Maintain current knowledge of ISO 13485
- Contributes to the overall compliance of RDH’s QMS with respective regulations and standards, and implement updates or improvements as needed
- Write SOP’s as well as other quality documents
Education
St. Lawrence University
2004 - 2009
Engineer's Degree in Engineering
Professional Skills
- In Quality Assurance to support development or manufacturing activities for tissue (including experience with 21CFR section 1271), medical device (including experience with 21CFR820 – QSRs for Medical Devices), pharmaceutical and/or combination products
- Strong analytical skills and problem solving techniques is required. Statistical application experience desirable
- Excellent organizational skills to effectively manage several projects in parallel
- Advanced problem solving skills - proven ability to identify and solve problems
- Effective communication, collaboration, and strong technical writing skills
- Demonstrate computer skills with Microsoft Office (Word, Excel, PowerPoint, and Visio) and Minitab
- Excellent Administrative and Analytical Skills
How to write Senior Quality Systems Engineer Resume
Senior Quality Systems Engineer role is responsible for basic, advanced, reporting, training, integration, database, purchasing, manufacturing, design, travel.
To write great resume for senior quality systems engineer job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Senior Quality Systems Engineer Resume
The section contact information is important in your senior quality systems engineer 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 Senior Quality Systems Engineer Resume
The section work experience is an essential part of your senior quality systems engineer 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 senior quality systems engineer responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular senior quality systems engineer position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Senior Quality Systems Engineer resume experience can include:
- Demonstrated and impactful project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams
- Builds strong knowledge of basic and advanced quality skills necessary for independent process evaluation & improvement
- Applies more advanced program management skills and experience to lead basic projects
- Strong analytical skills with deep knowledge of how to achieve process improvements and the conversion of data into meaningful business information
- Strong working knowledge of PLM concepts and functions, at the component, subassembly, and finished good levels
- Demonstrated strong leadership and partnership in working with diverse teams for improvements, issue resolution, or projects
Education on a Senior Quality Systems Engineer Resume
Make sure to make education a priority on your senior quality systems engineer resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your senior quality systems engineer 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 Senior Quality Systems Engineer Resume
When listing skills on your senior quality systems engineer 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 senior quality systems engineer skills:
- Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required
- Demonstrated experience in leading teams, organizing and managing projects and developing/coaching/guiding junior team members
- Demonstrated experience identifying and implementing process improvements in a regulated environment
- Organizational and communication skills providing the ability to multi-task in a fast- paced environment are required
- Experience working in a large medical device company with a global presence (previous Boston Scientific experience desired)
- Communicates effectively with cross-functional teams to execute team’s objectives
List of Typical Experience For a Senior Quality Systems Engineer Resume
1
Experience For Senior Quality Systems Engineer Resume
- Demonstrated experience with Domestic and International regulatory requirements and regulating bodies required
- Experience training and leading others in the use of complex PLM systems
- Previous experience of preparing and participating in external audits
- Collaborate in the identification and implementation of corrective actions while ensuring effective and timely completion of all corrective actions
- Experience working in a quality and compliance environment in the medical device industry (GMP) or similar
- Experience working with Quality Systems Regulations
2
Experience For Senior Quality Systems Engineer Resume
- Supply chain or manufacturing environment experience is desirable
- Follow-up on corrective actions to ensure they implemented on time and are effective
- Mentoring cross-functional CAPA teams on
- Working Knowledge in aerospace quality processes like SPC, PPAP, and PFMEA
- Manufacturing Pre-Review Leader
- Performing periodic audits of quality systems and raw material suppliers to ensure FMCNA and regulatory requirements are being maintained
- Performing trend analysis of quality data associated with FMCNA products and recommending corrective/preventive actions for problem resolution
- Lead project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans
3
Experience For Senior Quality Systems Engineer Resume
- Responsible for scheduling, planning, conducting, communicating and reporting on internal audit results
- Conducts training on quality concepts and problem solving tools including 5Why and Fishbone
- Involved in handling audit non-conformances, evaluating impact to compliance, and facilitating sustainable fixes
- Provide guidance during protocol incidents process, including reporting, investigations and approval of resolutions
- Support data gathering for regional, operating company, and global QPRs and QSMRs including ad-hoc requests
4
Experience For Senior Quality Systems Engineer Resume
- Adept communicating across organizational levels, serving as a company representative, and working as both a team leader and team member
- Takes the lead on risk reviews for product quality / compliance issues ensuring that key stakeholders are involved in the decision making process
- Resolve project roadblocks and obstacles by working with team members, project customers, escalating to management, and others as appropriate
- Maintain the quality of the engineering systems by working with Internal and External Auditors to control the projects and processes
- Ensure Quality Systems are compliant with changing regulatory environment (including standards)
- Assists the Regional QS Manager in developing the corrective action plans for any findings resulting from external audits
- Serves as Quality Approver on Engineering Change Orders (ECOs)/Document Change Orders (DCOs), Training Matrices, and other documents as requested
- Perform trouble-shooting, problem solving activities, and root cause analyses related to product or process non-conformances and CAPAs
5
Experience For Senior Quality Systems Engineer Resume
- Be the lead auditor for IATF 16949 and ensure the engineering teams’ compliance with the required specifications
- Coach and guide the engineering management- and project teams in the requirements and tools of the Quality Management System
- Develop tools to support the Engineering Quality System such as Integrity, Windchill, Clarity and Sharepoint
- Provide required training to support qualification activities
- Assist the Regional QS Manager with Coordinating Product Recalls
- Work with designated Change Owners to support the accurate creation and routing of Change Notices (change orders) in Windchill 10 PLM system
- Assist users in troubleshooting Windchill 10 PLM issues
- Lead special projects including improvements to quality systems
6
Experience For Senior Quality Systems Engineer Resume
- Coordinates internal corrective and preventative action activities using an 8D methodology as well as facilitate continual improvement activities
- Communicates significant issues or developments identified during quality activities and provides recommended process improvements to management
- Responsible for maintaining internal process for continuous compliance with corporate / global quality system and external requirements
- Lead and / or support Quality integration activities impacting the Arden Hills site and/or Rhythm Management division
- Promote a work environment that supports the Quality Policy, Global BSC Quality System, Continuous Improvement and Winning Culture at Arden Hills
7
Experience For Senior Quality Systems Engineer Resume
- Support Quality Planning process
- Act as a team member in supporting quality disciplines, decisions, and practices
- Engage with key areas of the business to collate information and trending for QPRs and QSMRs
- Facilitate change management activities resulting from the standardization of QPR and QSMR processes
- Fluent verbally and in writing in English as well as in German
- Provide system implementations or updates for new engineering processes
- Provide overall Quality Systems leadership for including
8
Experience For Senior Quality Systems Engineer Resume
- Practiced in presenting to various levels of management
- Auditor Lead Assessor training
- Formulation from cross functional teams key process Indicators supporting management review
- Coordination, leading, and implementation of quality data base tools, SW systems or EQMS technical solutions
- Advanced proficiency with the Microsoft Office Suite required; metric and KPI reporting
- Develops QMS training plans
9
Experience For Senior Quality Systems Engineer Resume
- QSR compliant complaint and reporting processes
- Makes tough decisions that impact the program, team, or individuals, while supporting decisions with clearly communicated rationale
- Applies understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to support work with little or no supervision
- Leads process improvement work
- Lead the development of the Engineering Quality System, tools and infrastructure and ensure the system is developed, managed and used in accordance with the Policy Manual and supports appropriate specifications
- Conduct regular reviews of engineering procedures, support work to identify and implement process improvements and produce monthly reports demonstrating Progress
10
Experience For Senior Quality Systems Engineer Resume
- Ensure that the validation requirements are documented to provide direction for meeting the validation needs of the customers, associated regulatory bodies and West functional groups. Provide guidance to system/process stakeholders as to content and format of Validation life cycle documentation
- Support Engineering and Operations groups during the process development and Validation phases of customer products’ life cycles
- Assume the QA responsibilities for reviewing and approval of validation life cycle documentation (PDD, IOQ/PQ protocols, protocol addendums, summary reports, etc)
- Min 5-10 Years' experience in Quality Systems Management in the Medical Device /Component Industry
- A positive attitude in dealing with people
- Learn and adapt to varying demands and situations
List of Typical Skills For a Senior Quality Systems Engineer Resume
1
Skills For Senior Quality Systems Engineer Resume
- Experience with all elements of the medical device or IVDD quality management system including extensive experience in the following areas
- Communicate effectively while working with cross functional teams
- Experience in quality systems, quality engineering, or compliance (or combined experience) in the medical device or other regulated industry
- Effective at prioritizing of tasks and responsibilities within a fast-paced, dynamic environment
- Highly developed writing, communication, and interpersonal skills with the ability to work on diverse teams located at different geographical locations
- Computer Skills (Word, Excel, PowerPoint, Minitab, Visio, Microsoft Project/scheduling, Metric/chart creation)
- Demonstrated skill with information systems and technology
- Communicate effectively with different levels of personal
2
Skills For Senior Quality Systems Engineer Resume
- Bachelors with 7-10 years of relevant experience or Masters with 3-7 years of relevant experience
- Working knowledge of Microsoft office products (Word, Excel, Access, and Project) is required. Experience with Agile and SAP is desirable
- Providing support to departmental, functional, divisional, and corporate quality goals and priorities
- Experience in developing and implementing processes and procedures to comply with regulations and standards across the organization; and providing training
- Strong working knowledge of creating and maintaining accurate and complete DMR and DHF in PLM
3
Skills For Senior Quality Systems Engineer Resume
- Effective in collaborating and partnering with all levels of management and displaying an appropriate level of assertiveness
- Experience authoring and presenting technical and/or QMS training to cross functional departments
- Experience conducting audits in a manufacturing and/or medical device environment
- Related experience with implementing quality systems in manufacturing environments
- Good understanding of Agile, design controls and risk management methodologies
4
Skills For Senior Quality Systems Engineer Resume
- Good understanding on translation of voice of customer input to requirements
- Experience and knowledge of Lean Manufacturing and Six Sigma methodology principles
- Experience in manufacturing plants and knowledge of plant processes
- Strong negotiation, decision making ability and a solutions oriented mindset is required
- Previous experience in a quality systems engineering position, specifically within automotive industry is a value add
- Proactive, self-motivated candidates with an attention to detail and experience working in a crisis management environment are encouraged to apply
- Related experience in quality engineering in a software development environment
- Experience dealing with SW only products highly desired
- Cross functional experience working collaboratively with a team
5
Skills For Senior Quality Systems Engineer Resume
- Experience supporting external audits in the areas of doc and data controls
- Medical device engineering experience
- Experience communicating with NBs and CAs
- Good understanding of product development lifecycles; design control through post-market surveillance
- Good understanding of CAPA systems and implementation
- Experience preparing for external QMS and regulatory audits, audit room manager/coordinator, train and prepare staff
- Initiates CAPAs and investigations to resolve all good inwards receiving inspection out of specification materials
- Experience in Lean (Six) Sigma
6
Skills For Senior Quality Systems Engineer Resume
- Work with vendors, engineering staff members (within and outside the unit), and Operations personnel in an effective and positive manner
- Experience with statistical process control software
- Experience with SAP, Quality Systems Basics tools
- Experience in FDA environment highly desired
- Support any Validation activities
- Experience in Quality and/or Compliance within the Medical Device Industry, Pharmaceutical and / or other highly regulated Industry is required
- Specific experience in corrective and preventive action efforts is required
7
Skills For Senior Quality Systems Engineer Resume
- Keep current with all Industry standard practices and FDA requirements for validation, change control and complaint handling
- Act as an effective leader or team member in supporting quality disciplines, decisions, and practices
- Reviewing process improvement recommendations and participating in planning and implementing manufacturing changes with the manufacturer
- Reviewing and approving corrective action plans and maintain CAPA tracking metrics
- Maintaining and updating training modules, policies and procedures
- Leading the development, review, and improvement of manufacturer quality plans and manufacturing processes related to FMCNA products
- Reviewing and complying with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations
8
Skills For Senior Quality Systems Engineer Resume
- Documenting and improving the Quality Management System
- Understanding of how MES and SAP systems work and integrate with PLM system
- Training/certifications in Quality Management System Requirements (ISO 13485) and FDA Quality System Regulation (21 CFR Part 820)
- Understanding of medical device industry and products
- Leading internal audits within a medical device/IVDD environment
- Ensuring quality systems are established and maintained in compliance with applicable local ordinances, state statutes, and Federal regulations, and other laws
- Maintaining knowledge of all processes and quality principles to assist with daily operations and continual improvement activities
9
Skills For Senior Quality Systems Engineer Resume
- Coordinating Internal Audits and maintain ISO compliance for the FMSCO division
- Improving, deploying and maintaining plant quality management systems
- Driving quality improvement using engineering best practice, statistical techniques, and Lean Six Sigma methodologies
- Understanding and facilitation of Risk documentation to ensure compliance with ISO 14971
- Providing support with preparation of, coordination, and management of regulatory agency and 3rd party inspection
- Developing, recommending and leading quality investigations, corrective and preventive actions
- Assessing training needs to raise site awareness and competency in regulatory and quality management systems and requirements
- Collaborate with Manufacturing Engineering, customers, and suppliers to improve manufacturing processes and develop methods to eliminate quality problems
- Uses analytical thinking and reasoning to anticipate implication/conclusions of a complex situation or issue
10
Skills For Senior Quality Systems Engineer Resume
- Adept working knowledge of US and International regulations including 21 CFR 806 & 820, ISO 13485:2016, MDD, and JPAL
- Responsible for being the prime quality representative for design control projects – new product development as well as sustaining efforts
- Implement systems to give trending and early warning of supplier performance to avoid interruption of component supply
- Create and distribute status reports to Engineering/Technical staff to aide them with tracking of CAPAs
- Performs QMS training for all new and existing employees
List of Typical Responsibilities For a Senior Quality Systems Engineer Resume
1
Responsibilities For Senior Quality Systems Engineer Resume
- Experience working to interpret and apply quality regulations and standards
- Perform timely and adequate effectiveness checks and monitors corrective action progress for audit non-conformities and other opportunities for improvement
- Willing to travel to subcontractor manufacturing sites with overnight stays to conduct facility and process audits and meetings to resolve product issues
- Compile write training material and conduct training sessions on improvement tools methodologies
- Support efforts in creating best in class Quality System procedures across Abbott sites
- Familiarity with a learning management system
- Lead and give direction to team members on all aspects of Quality Systems
- Provide clarification and guidance to teams on overall quality system with emphasis in design controls
2
Responsibilities For Senior Quality Systems Engineer Resume
- Responsible for review and/or approval of design history file documentation in support of design controls
- Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support
- Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release
- Active participant in the development of product requirement, product system hazard analysis and design reviews
- Reviews and approves Change Orders and/or Electronic Release Authorizations for new releases or design enhancements
3
Responsibilities For Senior Quality Systems Engineer Resume
- Ensure product technical files and Design History Files are complete and auditable
- Work with client’s process owners to fully utilize MasterControl’s capabilities to enhance their processes
- Manage NC/CAPA System, which includes
- Providing quality engineering support to quality systems/regulatory affairs functions and to assigned manufacturing locations as required, based on both in-process manufacturing and post-market quality analyses
- Analyzing processes, work operations, quality records, complaints, and other sources of data to identify existing and/or potential causes of failures and where failures and potential failures are identified, investigating and assisting in making recommendations necessary to correct and prevent recurrence
- Reviewing new documents and changes to existing documents to ensure enhanced quality and productivity, while maintaining compliance with FMCNA Corporate and FDA requirements
- Works closely with purchasing and operations to enable compliant completion of AQAs
4
Responsibilities For Senior Quality Systems Engineer Resume
- Materials Review Board and CAPA Documentation Reviews component and process change requests
- Ensures that all QMS documentation and quality records for good inwards receiving inspection is in place, accurate and compliant with external and internal requirements
- Materials Management Support (AQA, Direct to Stock, QC Inspection)
- Ensures that all QMS documentation and quality records are in place and accurate for suppliers and received components
- Processes CAPA documents and tracks status of corrective action to ensure CAPA documents are complete and all corrective actions are closed
- Supports all Material Review Board activities such as investigation on hold items and disposition as appropriate
- Prepares and distributes CAPA documentation for use in production and other company processes
5
Responsibilities For Senior Quality Systems Engineer Resume
- Monitors and reports progress on corrective action plans
- Follow-up on internal audit reports and corrective actions
- Ensures that complaint investigations are completed in a timely manner and their progress is tracked accordingly
- Manages customer complaints and triages them to ensure that investigations are allocated to the correct personnel (e.g. Engineers)
- Provides daily leadership and management to the QC team at Rossendale to ensure cost effective compliance with national and international regulations and corporate policies. Drives systematic improvements for the QC activity to ensure the timely approval of materials in a compliant manner
- FMSCO Lead ISO Auditor, responsible for coordinating ISO compliance audits for the FMSCO division and ISO 9001:2015 standard migration
- FMSCO New Product/Technology Introduction Gate Review Coordinator
- FMSCO Run Request Database Maintenance and Administration
6
Responsibilities For Senior Quality Systems Engineer Resume
- Pilot Plant MDI Database Maintenance and Administration
- Product Lifecycle Management (PLM) Support
- PLM - Experimental Process Project Leader
- Act as site SME for Windchill 10 PLM system
- Provide leadership and guidance to project teams on change control and configuration management strategies for new product development, design changes, and manufacturing process changes
7
Responsibilities For Senior Quality Systems Engineer Resume
- Train users to perform roles in Windchill 10 PLM system workflows
- Contribute actively to internal BSC global communities of practice in the areas of document, record, and data control
- Position requires interaction with external customers and internal personnel at all levels of the organization. Interaction is quite often providing the controlled interface between internal personnel and a customer or supplier representative
- Maintains and improves quality management system for NA
- Leads internal/external IATF registrar, VDA, and APQP audits
- Maintains Layered Process Audit System
8
Responsibilities For Senior Quality Systems Engineer Resume
- Leads teams to reduce non-conformance and scrap
- Assists APQP department in process verification of program launches
- Establishes program to evaluate precision and accuracy of process, test, and measurement equipment
- Plans and conducts the analysis, inspection, design, test, and/or integration of QMS and product / process data to assure the quality of the assigned product or component meets customer requirements
- Applies statistical process control (SPC) methods for analyzing data to evaluate the current product and process changes
- Prepares and presents technical and program reports and information to team members and management
9
Responsibilities For Senior Quality Systems Engineer Resume
- Directly supports ISO 9001 quality system and supports the implementation and management of the site quality system and procedures
- Subject matter expert responsible to identify gaps at the plant level and execute improvement activity. Execute or facilitate all aspects of APQP and Part Approval and sign-off for both suppliers and customers, manage revisions of process control documents such as PFMEAs, control plans and other quality tools to ensure compliance
- Lead and conduct Supplier Assessments to qualify potential new suppliers or evaluate existing suppliers. Works with the Supply Chain organization to develop new suppliers as appropriate
- Reviews supplier PPAP submissions including control plans and assists with control plan creation where necessary. Ensures all appropriate Special Characteristics are included, that reaction plans are adequate and customer approval is obtained where necessary
- Manage the internal audit program by leading internal audits, timely audit scheduling, and training to ensure regulatory compliance
- Develop, maintain and improve processes and procedures for various processes within the quality management system and where necessary, provides training
- QS Site subject matter expert (SME) for Internal/External Audits and applicable regulatory requirements
- Apply and exercise audit readiness skills and techniques within the organization and participate in external regulatory audits as a member of the Siemens quality management team
- Coordinate, train, and manage audit readiness and act as the external audit ready room manager
10
Responsibilities For Senior Quality Systems Engineer Resume
- Participate and collaborate with Business Units/Areas, departments to ensure QMS compliance and align local SOP’s as required with common Business Unit SOP’s
- Be a leader in introducing, coaching, and coordinating business improvements through training, new quality tool development, implementation, and authoring or editing SOP’s
- Support QA releases of final product release, executed batch records, labeling, and raw materials. Correspond with appropriate stakeholders to ensure regulatory requirements/specifications are met
- Author, maintain, and present KPI’s through data exporting and metrics with professional presentations
- Lead improvement projects within the QMS through supportive tools and databases
- Develop and maintain detailed project schedules in Microsoft Project
- Track and report resource management, project deliverables, and key milestones
- Responsible for the communication and documentation of internal and external compliance-related information including changes in external requirements, corporate requirements, and local changes to ensure continuous compliance
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