Quality Management System Resume Sample
Cornell Schuster
32477 Tyrel Vista,
New York,
NY
+1 (555) 669 6803
Work Experience
Quality Management System Specialist
02/2016
-
PRESENT
Dallas, TX
- Sustain and support the complaints management system as needed
- Develop and manage relationships with personnel in all functions and levels to ensure the delivery of the highest standards of internal and external customer satisfaction
- To manage workload effectively in order to achieve personal and departmental objectives
- To show initiative in problem solving by identifying and recommending solutions to problems encountered
- Ensures professional development of self and personal knowledge of applicable parts of GMP, GDP, ISO 9001, ISO 13485, US FDA 21 CFR Part 820 and any other applicable quality standards or regulations concerning Medicinal Products and Medical Devices
- Good working knowledge of company products, processes, procedures and personnel
- Experienced working within Quality Assurance, preferably within the Medical Device / Pharmaceutical Industry
- Awareness / understanding of the Medical Device Directive, GMP, GDP, ISO 9001, ISO 13485, 21 CFR Part 820
Quality Management System Supervisor
09/2013
-
09/2015
San Francisco, CA
- Experience in an IS/IT GxP-related field within a biotechnology or pharmaceutical organization
- Provides support for special quality projects
- Ensures and maintains a state of inspection readiness. Performs in various quality functional areas and maintain expertise
- Coordinates change control documentation and approval process
- Responsible for overseeing the controls and quality standards for Quality Systems, validation, CAPA, NC, Internal Audits, Document Management software systems
- Prepares for and facilitates audits and inspections. Monitors trends, identifies issues, recommends and implements appropriate actions
- Internal audit program is established and executed
- Deviations and findings are recorded, corrective and preventative actions defined and implemented in due time
IMS Business Analyst Intern Quality Management System
05/2008
-
05/2013
Los Angeles, CA
- Strong analytical and good communication skills are essential together with the ability to manage personal workload to ensure high standards are maintained
- Trained auditor desirable
- Awareness / understanding of the impact of the department on the business
- Knowledge of the potential for product liability, alleged adverse incidents and potential Field Safety Corrective Actions
- Training Implementation and Deployment
- Manage the SWS’s Business Management System according to the GE Grid Solutions and to GE corporate requirements
- Acts as the Management Representative for the company’s ISO 9001:2008 certification and champion the transition to ISO9001:2015 when appropriate
- Review client’s quality management system
- Manages the corrective action and preventive action (CAPA) roadmaps and plans on an effective and integrated fashion with GLOBE’s strategic and operational master plans
Education
Whitworth University
2004 - 2008
Bachelor's Degree in Engineering
Professional Skills
- Strong computer skills including experience with SAP, EtQ, and SFDC
- Effective planning, organizing and priority-setting skills
- Strong influencing, communication and diplomacy skills
- Strong analytical skills with the ability to summarize results and recommendations for the improvement process
- Excellent English and French communication skills, both written and spoken. Spanish would be an asset
- Strong analytical and quantitative skills; statistically literate and familiar with
- Advanced Auditing/Compliance - Applies advanced auditing and quality compliance skills to identify and manage risks/compliance
How to write Quality Management System Resume
Quality Management System role is responsible for analytical, auditing, training, spanish, english, travel, integration, security, analysis, reporting.
To write great resume for quality management system job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Quality Management System Resume
The section contact information is important in your quality management system 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 Quality Management System Resume
The section work experience is an essential part of your quality management system 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 quality management system responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular quality management system position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Quality Management System resume experience can include:
- Effectively lead a team of at least 3 QA members in achieving department and individual team members’ objectives
- The processes and their controls are adequately documented and effectively deployed to all staff globally
- Practical quality system auditing experience
- Applied experience in PPI tools and Lean techniques (investigations, Root Cause, Containment activities)
- Prioritization and development of audit plan for product centers and service sites aligned with the QMS
- Provide effective quality related awareness education, training and support as necessary
Education on a Quality Management System Resume
Make sure to make education a priority on your quality management system resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality management system 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 Quality Management System Resume
When listing skills on your quality management system 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 quality management system skills:
- Interpersonal skills, good verbal and written communication required, being able to work in a team environment and with other cultures
- Advanced Auditing/Compliance - Applies basic auditing and quality compliance skills to identify and manage risks/compliance
- Alternatively 5-7 years prior quality experience in upstream or midstream oil and gas equipment manufacturing or services environment
- Intermediate Customer Specifications Management - Interfaces effectively with customers; ensures products meet
- Basic Business Acumen - Applies basic business acumen to partner effectively with business counterparts
- Advanced computer skills: Microsoft Office software (MS Word, Access, PowerPoint, Excel, Project)
List of Typical Experience For a Quality Management System Resume
1
Experience For Quality Management System Specialist Resume
- Ensure that regular management reviews covering the effectiveness of the Quality Management System take place and that the decisions and actions are formally documented
- Applied knowledge and experience working with Quality Management System requirements such ISO9001, IATF16949, AS9100, or ISO17025
- Support the IPS Leadership Team in the effective deployment of the Quality Management System across all the locations
- Experience in development and authoring of quality procedures, work instructions and forms
- Good collaboration with Global team on quality and quality related activities. flow down Hon Aerospace quality requirements to sites
- Lead organizational response to critical quality issues. Interact as needed with customers, both proactively and reactively, to demonstrate quality commitment
- Ensure site level accuracy and timely inspection/calibration of monitoring and measuring devices
- Identify training needs for audit resources in AME and organize training accordingly
- Designation of finding severity (major/minor/requires correction/observation) and proper assignment of actions to functional owners
2
Experience For Quality Management System Manager Resume
- Provides periodic updates on QMS implementation status, audit plan and finding trend analysis, and action status for the product center and service sites
- Ensure site adherence to ISO9001 Standard and the underlying quality principles
- Gather information from production, service, development and supporting activities
- Support the maintenance of ISO 9001, IRIS and other relevant certifications for all AME sites including the local application of the BT Quality Policy
- Establish the climate that encourages an open two-way channel of communication whereby employees exchange ideas/suggestions and share information
- Works with the GPOs (Group Process Owners) and CPOs (Company/Country Process Owners) to ensure that the processes, procedures and related documents in the management system are consistent and comprehensive
- Defines, plans, monitors, and reports on quality audits, supply base, corrective actions and procedural enhancements which address Thales’s business requirements as well as supporting the business functionality
- Three (3) years’ experience with compliance level interaction with the FAA in both the FSDO and MIDO offices
3
Experience For Quality Management System Leader Resume
- Possess and maintain a valid Driver License and a record that meets our parent company’s insurance standards
- Design Control process owner for Health Care Business Group
- Collaboratively redesign Design controls process for simplicity, ease of use and implement standardized process globally at all Health Care Business Group design centers
- Establish mechanisms to gather regular input from global sites and improve process to ensure compliance and supports product development to changing global regulations and business needs
- Consults with product development teams, division operating committee members and project managers to ensure Design control are followed through product development lifecycle
- Coaches Product development leaders on Design Control process and use of it
- Establish baseline metrics for current processes and propose standard metrics to be collected in future state to measure effectiveness and efficiencies to support value realization
- Lead change management required to implement standardized Design Control process globally and ensure adoption of it to support growth and value realization
- Deployment, maintenance and continuous improvement of the Quality Management System (QMS) throughout all functions at the designated ALCs, with strong focus on process consistency and capability to meet customer and other stakeholder requirements
4
Experience For Continuous Improvement & Quality Management System Manager Resume
- Define verification and validation methods to ensure program is monitored for efficiency, effectiveness and cost impact to meet company strategic goals and to satisfy various customer requirements for contractual commitments
- Maintain key elements of the QMS i.e. Customer complaint resolution, Root Cause Analysis, Corrective and Preventive action, Internal Audit protocol, Management Review
- Provide leadership in enabling associates at all levels through QMS and continuous improvement training towards improvement of the operating system
- Ensure quality of procedure writing (e.g. grammar, spelling, proper tense, etc.)
- Facilitate formal quarterly Management Review process
- Ensure readability of procedure content through the use of succinct, specific, accurate and simple language that conveys sufficient information
- Partner with Business Process Experts and Business Process Owners in respective compliance domains during creation of corporate procedures and disposition of stakeholder feedback
- Lead the Quality Management System harmonization between the division’s sites
5
Experience For Quality Management System Program Manager Resume
- Work with US team/APAC Quality team to develop and deliver a robust Quality Management System (QMS) for APAC, based on ISO 9001:2015 standard
- Perform internal audit like PPAP audit including documents effectiveness audit, supplier processes audit, in order to identify the opportunities for improvements
- Experience with cross functional disciplines and multi culture team based environment
- Manage APAC quality document SharePoint
- Working experiecne in Quality Management System (QMS) based on ISO 9000:2015 standard in manufacturing operations including direct experience in documentation control
6
Experience For Quality Management System Supervisor Resume
- Thorough understanding and practical experience in deploying ISO 9000:2015 standard
- Travel in Asia – up to 40%
- Implement the Sika Management System, SMS, for Marion
- Provide local site management with technical assistance required to formulate new or revised quality control procedures and systems
- Provide management with regular reports regarding compliance status, specific action items, problems and opportunities. Monitor and report quality assurance organization performance
- Excellent written, communication and strong critical thinking skills
- Experience leading and rolling out Projects and updates to the organization
7
Experience For MTB Quality Management System Manager Resume
- Auditor experience and report writing
- Understand, track and implement customer specific requirements as required
- Investigate and determine root causes for Quality Improvement Requests, QIRs
- Provide corrective and preventive techniques to insure continuous improvement of the QMS
- Conduct PCP Audits as directed by management
- SAP Capable, performs QA transactions in Quality Module
- Inner faces with Customer Quality Systems (OEMS)
8
Experience For EDN Quality Management System Associate Resume
- Perform other projects or assignments as required
- Function as a strong Quality liaison to other functional departments, by providing meaningful quality support and ensuring productive cross-functional communication
- Collaborate and or support our functional leaders to develop effective quality procedures to meet compliance requirements and/or provide solutions to ensure a proactive quality model is in place
- Perform a variety of quality reviews and approvals related to the document management process, including facilitating organizational compliance to the training matrix program
- Lead and perform internal audits as needed
- Lead role to facilitate business integrations into the Quality Management System (inter-divisional or new acquisitions) for readiness state prior to target audit cycle
- Lead, review and approve Quality Issue Reviews or CAPA investigations performed by the functional staff to ensure that corrective action plans are thorough, complete and timely
- Work with process owners to fully understand and provide guidance on appropriate investigation root cause, containment, corrective and preventative actions are thoroughly addressed to assure repeat deviations do not occur
9
Experience For Quality Management System Lead Resume
- Develop and report quality metrics as needed for score cards and quality review meetings
- Provide functional support, oversight and enforcement of local and corporate record retention policies to ensure continued compliance
- Develop, guide and facilitate the risk management processes within the quality team or with functional departments
- Participate in quality improvement projects and tasks as assigned by the Quality Manager
- Review and approve customer quality survey forms and quality agreements to accurately reflect our quality scope and commitments
- An experienced team builder with ability to work collaboratively with various departments to identify and implement solutions to address quality/compliance issues
- Work well in a matrix environment, the ability to multi-task, ability to solve practical problems and deal with a variety of changing situations
- Use of Microsoft Word, Excel, PowerPoint, Outlook and Visio
10
Experience For Quality Management System Business Analyst Resume
- Potential for 30% travel for related projects or audit support
- QMS procedure communication and implementation at the product centers.
- Revision (document control) and modification of the QMS as required by industry specification and standards and as required to meet Company objectives
- Development and implementation of the QMS implementation plan and status for each product center
- Documentation of findings as result of audits and follow through with business functional owners to address open actions as result of findings
- Provides site leadership for ISO/ASME and other 3rd party (external) audits required to ensure compliance to industry requirements or contract compliance
- Ensures successful implementation of Quality Management System (QMS ISO 9001:2015) and operates according to corporate requirements. Identifies opportunities for improvement of the QMS and recommends/ implements actions to take advantage of these opportunities
- Ensure that the organization’s Quality Management System conforms to customer, internal, ISO 9001, and regulatory/legal requirements
List of Typical Skills For a Quality Management System Resume
1
Skills For Quality Management System Specialist Resume
- Demonstrated ability to perform long-term project planning, team building, and cross discipline leadership
- Experience working with AS9100 and/or similar QMS standard
- Experience with using MasterControl Quality Management Software
- Experience on business processes management in a multi-site manufacturing environment
- Experience interfacing with Customer on quality and/or technical issues
2
Skills For Quality Management System Manager Resume
- Experience in healthcare service management including quality management
- Applied experience of implementing ISO9001
- Demonstrated ability to successfully work within a team and believe in the concept of ‘team work’
- Experience with the global demands of the role specifically in the healthcare regulatory requirements
- At least two years’ experience in a regulatory affairs and quality assurance environment an asset
- QMS audit experience
3
Skills For Quality Management System Leader Resume
- Valid Washington State driver’s license is required
- Lead Auditor experience w/certification
- Applied experience in ISO 13485
- PPI or lean experience
- Upervisory or managerial experience
- Demonstrated knowledge in statistical process control and application of Statistical Process Control in plant and laboratory environments
4
Skills For Continuous Improvement & Quality Management System Manager Resume
- Five (5) years of experience in Aircraft Maintenance
- Audit experience
- Support all functions in the management of corrective and preventive actions, as well as consolidation and reporting
- Experience in Manufacturing, Quality or related role
- Issuing and maintaining of all QMS relevant procedures also including initialize and optimization of such procedures
- Understanding of customer specific requirements
- Managing complexity and “hands-on” operational orientation
- Frequent talking, writing, listening
5
Skills For Quality Management System Program Manager Resume
- Technical understanding of semiconductor manufacturing process
- Basic Lean Manufacturing Thinking and Knowhow
- Continuously develop the Quality Management system with the focus of building in Quality Assurance rather than relying on Quality Control approach
- Continuous improvement mindset, being able to challenge the status quo
- Basic Understanding of statistical process control programs
- Report on process performance and maturity, including KPI reports for the management
- Drive Continuous Improvement and Cost of Quality (CoQ) initiatives to bring the business long-term added value
- Attend QMS conference call meeting and follow up on actions required
- Conduct according assessments
6
Skills For Quality Management System Supervisor Resume
- Establish all certification schedules and activities including internal and external audits as well as documentation review
- Support the business by continually improving the current Quality Management System for compliance to local, federal, and ISO regulations
- Be updated of changes in process/product technology
- Automotive Core Tools (FMEA, SPC, MSA, APQP, PPAP)
- Perform internal quality assurance audits to 21CFR 820, ISO 13485:2003, 93/42/EEC and other applicable Standards to ensure corporate and regulatory compliance
7
Skills For MTB Quality Management System Manager Resume
- Develop, Maintain, and Comply with Internal Audit Schedule on an annual basis
- Ensure effective closure, by working with auditees to ensure comprehension, development, and execution of corrective/preventive action with regards to any nonconformance identified during audits. Create formal audit reports and assign associated corrective actions
- Develop/modify audit checklists as regulatory requirements change
- Identify areas of opportunity and support continual improvement of the Quality Management System (QMS)
- Identify, develop, and report QMS metrics
- Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of Stryker Orthopaedics continuous improvement initiatives
- Experience in Quality / in Operations or in a Support Function preferably in software industry
- A market conform salary
8
Skills For EDN Quality Management System Associate Resume
- Sit and work with computer
- Read written documents and use computer monitor screen frequently
- Diverse business background, preferably with direct experience in a J&J segment, with specific quality, and regulatory compliance competencies in the areas of customer service
- Practical and proactive approach
- Development of an open process and quality orientation
- Knowledge of international standards: IRIS (International Railway Industry Standard); ISO/TS 22163, ISO 9001, OHSAS 18001, ISO 14001 & CMMi
- Knowledge of computer tools (Excel, Word, Power Point, Project and SAP)
9
Skills For Quality Management System Lead Resume
- BS level education in technical field
- Deep technical knowledge in the areas of Quality Management System and Document Management
- Lead Auditor in ISO 9001
- Advanced Product Information/Documentation: Prepares product information and documentation that meet regulatory compliance requirements
- Intermediate Knowledge of Food Laws & Regulations - Stays up-to-date and ensures compliance with food laws and regulations
- ASQ Quality Engineer (or other) Certification
- Interpret data, diagnose problems, and initiate actions to prevent recurrence
- In-depth knowledge of Canadian Aviation Regulations and Safety Management Systems
10
Skills For Quality Management System Business Analyst Resume
- Deep knowledge of airworthiness and aviation standards including Transport Canada and Canadian Air Force regulations, and civil industry standards including AS9100 and 9110
- Good knowledge of Flight Safety Program for the Canadian Forces and the Flight Safety Information Management System (FSIMS)
- French and English communication (written and spoken)
- Six Sigma quality concepts and tools
- Basic Scientific Knowledge - Applies basic scientific knowledge & principles to identify & manage risk
- Advanced Product Information /Documentation: Prepares product information and documentation that meet regulatory compliance requirements
- Advanced Knowledge of Quality Standards & Quality Tools - Applies knowledge of quality standards and tools to enhance food safety and quality
- Support the deployment, evolution and improvement of BT Integrated Business Processes for the area of responsibility (site/region/division)
- Support the deployment, evolution and improvement of BT Integrated Business Processes for AME by taking into consideration our objectives of continuous improvement, quality, customer satisfaction and cost reduction
List of Typical Responsibilities For a Quality Management System Resume
1
Responsibilities For Quality Management System Specialist Resume
- Manages QMS documentation ensuring it is regularly updated reflecting the way the plant operates and the use of only active versions. Organizes and provides QMS training to employees. Manages Corrective Action Requests (CAR) to ensure proper investigations and timely implementation of effective corrective actions
- Manages the internal audit program, verifying compliance with the audit schedule and ensuring audits are conducted in an effective manner in order to contribute to improvement. Conducts QMS internal audits. Prepare the factory for all the compliance (e.g. UL, ROHS etc.) requirements
- Perform audit and preparation of factory for all customers’ visit and audit. Check and ensure all quality document and process flow are correct and up to date. Coordinate the customers’ audit and ensure closure of all audit finding
- Manages factory stop build/stop ship and inventories purge. Provide reports for management review for the status of the stop build/ship/purge and inventories control with quality disposition. Administrating meeting with various party to ensure proper communication of the Quality Alert
- Effectively present information and respond to questions from groups of managers, customers and engineering team members
- Strong knowledge of the system integrations
- APAC QMS sustain and improvement to make sure all sites QMS fully meet AS9100/ISO9001 requirements
2
Responsibilities For Quality Management System Manager Resume
- Assist Regional Quality Director to drive overall quality improvement in the region. Like customer escape reduction, support global team to drive quality related audit
- Manage the 3rd party Quality certification program to increase the demonstrated level of Quality compliance and superiority in the Marketplace
- Develop QMS talents in the region
- Develop and lead the site’s strategic quality objectives with input from Operations, the Global Quality Strategy Leader, Sales and Marketing leaders, business managers, R&D, technology leaders and customers
- Maintain quality certifications such as ISO9001 and any customer specific certifications
- Implement, maintain, and drive continual improvement of the site quality management system
- Influence leadership to support Quality initiatives; ensure top leadership engagement in the quality management system
- Develop and review quality performance indicators and drive/recommend organizational improvement programs for product, processes and procedures
3
Responsibilities For Quality Management System Leader Resume
- Operationalize E&I QMS processes for simplicity and to support business initiative to standardize and leverage best practices for improved efficiency and effectiveness
- Coordinate communication of the quality policy, quality principles, and quality performance within the site
- Ensure the corrective and preventative action systems are used to satisfy customers and promote improvements
- Coordinate and lead all aspects of internal, external 3rd party, and customer audits
- Demonstrated strong networking, interpersonal skills and professionalism to deal with all levels of management, personnel, customers and business representatives
4
Responsibilities For Continuous Improvement & Quality Management System Manager Resume
- Create a cooperative, safe and productive work environment that seeks input from all employees
- Engage, develop and lead work groups to facilitate accomplishment of goals
- Assist with the development and maintenance of Internal Audit Schedule (System, Process, and Product Audits)
- Analyze department quality systems and previous audit information from multiple sources
- Lead Auditor: assist with audit team selection and audit plan preparation
- Represent the audit team with management of the audited area
- Participate in the development and maintenance of Quality System metrics
5
Responsibilities For Quality Management System Program Manager Resume
- Support the preparation and execution of Quality Management Reviews at the site and P&L levels
- Ensure the Quality Management System is in compliance with the appropriate internal & external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, EU MDR, and individual country regulatory requirements)
- Drive development and/or modification of Stryker's regional/local Quality Management Systems
- Implement best in class QS practices and benchmark against industry leads and regulatory requirements
- In a project environment, lead and execute development and/or modification of Stryker's regional/local Quality Management Systems
6
Responsibilities For Quality Management System Supervisor Resume
- Co-ordinate all QA activities to ensure project milestones of assigned projects are met in accordance with QS development
- Customer visit/audit coordination and preparation
- Lead site level Management Review meetings
- Lead quality engineers, inspectors, auditors, analysts, and technicians
- ISO 9001:2015 / IATF16949:2016 and other industry standards as applicable
- Certified Quality Auditor (ASQ CQA or similar)
7
Responsibilities For MTB Quality Management System Manager Resume
- Verify processes of all AME functions
- Ensure the consistency of AME local processes development with BT processes
- Contribute to the development of process documentation for the Quality function
- Support functions and functional Business Experts in the integration of the different quality aspects in the documentation of processes and procedures
- Coordinate the activities of the documentation tool (SDD)
- Simplify and streamline tools and related processes
- Define the audit plan for AME based on BT guidelines and identify the needs in order to receive or maintain certifications and process improvement programs
8
Responsibilities For EDN Quality Management System Associate Resume
- Align the audit plan with region, sites and functions’ management in accordance with the timing and resources involved to ensure execution of the said plan
- Support sites in the implementation of these best practices
- Quality tools knowledge
- Support QMS audit
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