Runs the QA audit program for AI - powered logistics platform verifying compliance and identifying defects. Collaborates on training updates and SOP improvements for operational efficiency.
About the role
- Quality Engineer supporting medical device manufacturing and development to ensure product quality and regulatory compliance. Collaborating with cross-functional teams to drive continuous improvement and regulatory adherence.
Responsibilities
- Provide quality engineering support for manufacturing operations (in-house and contract manufacturing).
- Partner with Manufacturing to establish and maintain robust in-process and final inspection criteria.
- Support process validation activities (IQ/OQ/PQ) and ensure compliance with ISO 13485 and FDA 21 CFR Part 820 requirements.
- Aid in production ramp-up and collaborate cross-functionally to address issues and drive continuous improvement projects.
- Develop and maintain the supplier quality program, including supplier selection, audits, and ongoing performance monitoring.
- Collaborate with Product Development and Manufacturing functions to qualify new suppliers and components.
- Manage supplier non-conformances and corrective actions to ensure timely and effective resolution.
- Ensure compliance with design control requirements (21 CFR 820.30, ISO 13485, ISO14971).
- Author, review, and approve design control documentation (Design History File, risk management files, verification/validation protocols and reports).
- Support design transfer activities to manufacturing.
- Collaborate with cross functional teams to ensure design and manufacturing changes are assessed and implemented according to applicable regulations.
- Champion for quality initiatives and improvements.
- Performs gap assessment of external standards.
- Lead root cause investigations and implement effective corrective and preventive actions (CAPAs).
- Support internal and external audits.
- Supports regulatory submissions as needed.
Requirements
- 7+ years of quality or manufacturing engineering experience in medical devices
- BS in Engineering (preferably Electrical, Mechanical or Biomedical).
- Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and applicable IEC/ISO standards (e.g., IEC 60601).
- Strong interpersonal, and communication skills
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