Job Summary:
The Quality Systems Engineer II drive TMC’s Corporate CAPA Program to ensure it is compliant with applicable global Quality System regulations (i.e., 21 CFR Part 820, ISO 13485:2016, MDR etc.), effective, and efficient in dealing with quality issues.
Job Details:
- Support the management and effectiveness of the Quality Management System, primarily the CAPA system by:
- Establishing and maintaining CAPA process metrics
- Providing guidance to CAPA Teams
- Participating on CAPA Teams as needed
- Reviewing content of CAPA root cause investigations, corrective actions, effectiveness criteria, and supporting data for adequacy, logicality, completeness, and compliance to regulatory and procedural requirements
- Being responsible for approving corrective and preventive action plans, implementation of required activities and objective evidence, and effectiveness verification
- Teaching and mentoring CAPA owners on root cause analysis and technical writing
- Organizing the Stewardship reviews of CAPA documentation
- Managing the CAPA portfolio of projects to ensure these issues are being managed in a timely and compliant manner.
- Facilitating activities related to the CAPA Board Work with Organizational Stakeholders to ensure CAPA and other quality system requirements are well understood appropriately incorporated into CAPA documentation and Management Review
- Generate Quality System Standard Operating Procedures as required.
- Contribute to the development of Quality System training materials and deliver training where applicable.
- Contribute to the development of Quality System performance measures.
- Support FDA & third-party audits as required.
- Follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.
- Other duties as assigned.
Position Requirements:
Knowledge, Skills and Abilities (KSAs)
- Knowledge in 21 CRF Part 820, ISO 13485:2016, Medical Device Directive / Regulation.
- Strong computer knowledge (MS Office), technical writing skills and proofreading ability.
- Ability to develop, communicate, and support the interpretation and implementation of comprehensive quality systems/regulatory requirements.
- Advanced skill in developing and maintaining spreadsheets, pivot tables, metrics, statistical applications, charts/graphs, and user-friendly reports.
- Demonstrated ability to lead a group of participants from problem statement, root cause identification, and verification of effectiveness.
- Demonstrated ability to interact with all levels of managements, co-workers, and regulators.
- Strong decision-making and prioritization skills.
- Strong written, verbal, and interpersonal communication skills.
- Strong organizational and presentation skills.
Background Experience:
- Position requires a 4-year degree in engineering or a scientific discipline or equivalent work experience.
- Minimum 2 years’ experience in a Quality Engineering, Compliance, or other related Quality System role(s) in a medical device or pharmaceutical company
- Experience performing root cause analysis/investigations.
- Experience supporting a regulated manufacturing operation.
- Experience with electronic quality system tools.
- Six Sigma Black/Green Belt Certification a plus
- ISO 13485 Lead Auditor Certification a plus
