Product Quality Engineer (New Product Development)

Marlborough, MA, US • Posted 7 days ago • Updated 6 days ago
Contract W2
No Travel Required
On-site
$50 - $54/hr
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Change Control
  • Conflict Resolution
  • Lean Six Sigma
  • Corrective And Preventive Action
  • Design Controls
  • FMEA
  • IQ
  • ISO 9000
  • Manufacturing
  • Medical Devices
  • NPI
  • OQ
  • PQ
  • Problem Solving
  • Product Development
  • Quality Assurance
  • Recruiting
  • Regulatory Compliance
  • Risk Management
  • Test Methods

Summary

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

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91099677
  • Position Id: 8924636
  • Posted 7 days ago
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