Product Quality Engineer (New Product Development)

Company: Talent Groups
Location: Marlborough
Posted on: March 31, 2026

Job Description:

Job Description We are hiring a Quality Engineer II to support new product development, manufacturing transfer, and commercial product quality in a biotech environment. This role partners with cross-functional teams to ensure compliance with design controls, validation, and regulatory standards. Key Responsibilities: Support NPI/NPD activities and product lifecycle quality Ensure design controls, DHF, and risk management (FMEA) compliance Support validation (IQ/OQ/PQ), test methods, and equipment qualification Manage change control, deviations, CAPA, and nonconformances Assist with customer complaint investigations Requirements: Bachelor’s degree in Engineering, Biological, or related field 3–5 years of Quality Engineering experience (ISO 9001 or similar) Experience in NPI/NPD and design controls Knowledge of biotech/medical device products and bioprocessing Strong problem-solving and organizational skills Preferred: ASQ CQE/CRE, Lean Six Sigma experience

Keywords: Talent Groups, Portland , Product Quality Engineer (New Product Development), Engineering , Marlborough, Maine