Quality Engineer
Quality Engineer
Position Summary
The Quality Engineer will support quality system activities across the product lifecycle for medical devices. This role works cross‑functionally to help ensure products and processes meet applicable regulatory and quality requirements while supporting continuous improvement initiatives.
Key Responsibilities
- Support implementation and maintenance of quality system processes in alignment with applicable regulations and standards.
- Provide quality oversight for product development, manufacturing, and post‑market activities.
- Participate in risk management, design control, and change management activities.
- Support investigations, root cause analysis, and corrective and preventive actions (CAPA).
- Review and approve quality records and documentation to ensure compliance.
- Collaborate with cross‑functional teams including engineering, manufacturing, regulatory, and operations.
- Assist with internal and external audits and related follow‑up activities.
- Contribute to continuous improvement efforts and quality initiatives.
Qualifications
- Bachelor's degree in engineering, science, or related field.
- Experience in quality engineering within the medical device industry.
- Experience supporting Class II and Class III medical devices strongly desired.
- Working knowledge of medical device quality systems and regulatory requirements.
- Strong problem‑solving skills and attention to detail.
- Ability to work effectively in a cross‑functional, regulated environment.
Preferred Experience
- Exposure to product development and commercialization activities.
- Experience working in regulated manufacturing environments.
- Familiarity with risk management and validation activities.
FAQs
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