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 c

GMP, FDA, EMA, ICH

Q7/Q9/Q10, and 21 CFR Part 11. Strong interpersonal skills with the ability to communicate effectively across technical and non-technical teams. Perks and Benefits Medical, Dental, and Vision Insurance 401(k)

Program PTO and Sick Time Professional Development and Mentorship Unique Culture and Values Job Type:

Full-time Pay:

$90,000.00 - $110,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Paid time off Vision insurance Application Question(s): Will you now or in the future require sponsorship (including H1B transfer)?

Work Location:

In person