Demo

Product Quality Engineer (New Product Development)

Talent Groups
Marlborough, MA Contractor
POSTED ON 3/27/2026
AVAILABLE BEFORE 4/26/2026

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

Salary : $50 - $54

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