Manufacturing Quality Engineer
Company: Talent Groups
Location: Marlborough
Posted on: March 30, 2026
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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 , Manufacturing Quality Engineer, Engineering , Marlborough, Maine
