Quality Assurance Specialist

Quality Assurance Specialist

8-month contract

Onsite in Portland, ME

Key responsibilities:

• Lead incoming, in‑process, and final inspections
• Manage sterilization validations and sterile loads
• Oversee NCs, MRB, complaint investigations and failure analysis
• Coordinate CAPA lifecycle, root‑cause analysis and closure
• Interface with suppliers, contract manufacturers and consultants
• Support internal audits, calibration, receiving inspection and quality metrics

Qualifications:

• 2+years in medical device, pharma or biotech (device preferred)
• Strong experience with NCs, CAPA and RCA
• Familiar with FDA QSR (21 CFR 820), ISO 13485
• Experience with electronic QMS and sterilization preferred
• Bachelor’s degree preferred