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Senior Quality Assurance Engineer
2 months ago
Collaborate with Research & Development and Manufacturing teams to spearhead design control initiatives for the creation and production of medical devices while addressing product quality challenges. Deliver quality assessments during design evaluations. Offer insights and direction for project design strategies, risk management, design verification/validation, and process validation.
Key Responsibilities:
- Utilize technical expertise across various quality assurance domains, including design control, risk assessment, design verification, design validation, process validation, test method validation, statistical sampling, and data analysis.
- Engage with R&D on design verification and validation testing for new product introductions.
- Collaborate with R&D and Quality Engineers to formulate quality specifications and acceptance criteria.
- Conduct or oversee test method validations.
- Facilitate the integration of new equipment by reviewing specifications and associated qualifications.
- Draft or evaluate risk analysis documents, including product risk assessments and Failure Mode and Effects Analysis (FMEA).
- Contribute to the enhancement of quality system procedures.
- Work independently and demonstrate proactive motivation, effectively managing multiple projects with minimal oversight.
- Partner with R&D Engineers to prepare design and development documentation for Regulatory submissions.
- Address issues related to submission documentation in collaboration with R&D.
- Adhere to applicable laws and regulations, comply with Quality Management System processes, and uphold ethical standards throughout the organization.
- Perform additional responsibilities as assigned.
- Bachelor's degree in Engineering or a related discipline.
- A minimum of six (6) to eight (8) years of pertinent experience in Manufacturing, Quality Engineering/Quality Control, Operations, R&D, design control, risk analysis, design verification, design validation, process validation, test method validation, and data analysis.
- Proven knowledge of FDA and ISO medical device quality system standards (ISO 14971, ISO 13485, 21CFR820).
- Experience with electrical/electromechanical testing requirements (IEC60601 standards series).
- Familiarity with software requirements for medical devices.
- Demonstrated proficiency in statistical analysis techniques.
- Excellent written and verbal communication abilities.
- Strong computer skills, including proficiency in MS Word, Excel, Teams, Outlook, and statistical software (e.g., MiniTab, Design of Experiment DOE).
- Capability to provide technical leadership in process validation, test method validation, data analysis, design control, risk analysis, design verification, and design validation.
- In-depth understanding of the medical device design control process.
- Ability to comprehend the technology associated with MicroVention's products.
- Experience with active implantable devices and their requirements.
- Familiarity with mobile application software for medical devices and relevant standards.
- Prior exposure to medical device cybersecurity standards.
- Comprehensive knowledge of medical product quality assurance.
- Strong mathematical skills with a working knowledge of statistical tools.
