Medical Device CAPA Engineer

GrayMatter Partners, LLC • Salt Lake City, UT, US • published 2026-09-22 23:43:00.301221

Description

Join **GrayMatter Partners,** a fast\-growing life sciences consulting company making an impact in biotech and pharma innovation. We partner with leading organizations to navigate regulatory requirements, ensure validated systems, and maintain the highest levels of quality throughout the product lifecycle. We’re looking for passionate professionals to grow with us! We are seeking a highly experienced **Medical Device** **CAPA Engineer** to join our team. The ideal candidate will bring 5\+ years of hands\-on expertise in regulated life sciences environments. **Key Responsibilities:** * Own and manage assigned CAPAs through completion. * Provide guidance and coaching to CAPA personnel. * Support Quality System updates and modifications. * Ensure accurate, compliant, and timely documentation. * Identify opportunities to improve and accelerate CAPA processing. **Qualifications** * Bachelor’s degree in Engineering or related field (advanced degree preferred). * 5\+ years of Medical Device Engineering experience. * Strong knowledge of cGMP, FDA, EMA, ICH Q7/Q9/Q10, and 21 CFR Part 11\. * Strong interpersonal skills with the ability to communicate effectively across technical and non\-tec...

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