Job Title: Senior Quality Engineer
Description: We are looking for a skilled Quality Engineer to support manufacturing, biocompatibility, sterilization, and packaging validation for structural heart implants, delivery systems, and robotic devices.
Responsibilities:
- Monitor product quality during production, ensuring GMP compliance and adherence to internal quality standards.
- Lead nonconformance investigations, root cause analysis, and CAPA implementation.
- Conduct process validations (IQ/OQ/PQ) and develop validation protocols and reports.
- Collaborate with cross-functional teams to resolve quality issues and drive process improvements.
- Perform audits and inspections to identify quality enhancements.
- Oversee biocompatibility and sterilization processes, coordinating with R&D and third-party providers.
- Ensure proper packaging validation and finished goods release.
- Maintain accurate documentation and support regulatory compliance (FDA QSR, ISO 13485).
- Participate in internal and external audits.
Skills:
- Knowledge of process validation, GMP, and quality systems for medical devices.
- Strong problem-solving, organizational, and documentation skills.
- Effective communication and collaboration across teams.
- Detail-oriented, with the ability to work independently.
Requirements:
- Bachelor’s in Engineering or related field; Master’s preferred.
- 7+ years of experience in manufacturing quality engineering in the medical device industry.
- Familiarity with FDA regulations, ISO 13485, and cleanroom environments.
- Experience with CAPA processes and certifications (e.g., Six Sigma, ASQ CQE/CQA) is a plus.
