Quality Engineer II
$85,000–$115,000 year
On-siteMarlborough, Massachusetts, United States
Job Summary
Conduct quality engineering across new product development, manufacturing transfer, and commercial operations to ensure products meet regulatory and customer expectations. Apply validation principles and design controls in accordance with ISO standards, ASME BPE, and CE requirements while supporting NPI teams with Quality Engineering tools. Partner with cross-functional groups to verify deliverables, maintain Design History Files, and drive risk management activities including FMEA, design verification, and process verification. Execute change controls, review nonconformances and deviations, and lead customer complaint investigations to implement sustainable corrective actions. Utilize Lean and Six Sigma methodologies to improve processes and reduce risk within the bioprocessing environment.
Required Qualifications
- Bachelor's degree in Biological Science, Engineering, Physical Science, or a related discipline
- Demonstrated experience in New Product Development Quality Engineering
- Experience supporting biotech hardware, consumable products, and associated manufacturing processes
- Working knowledge of cell culture, filtration, and chromatography operations within a bioprocessing environment
- Minimum of 5 years of Quality Engineering experience within an ISO 9001 Quality Management System or equivalent regulated environment
- Internal auditing experience
- Strong communication and relationship-building skills, with the ability to effectively collaborate across technical and operational functions
- Ability to influence outcomes, navigate complex challenges, and contribute to informed, risk-based decision making
- Proven ability to drive results, manage competing priorities, and support continuous improvement initiatives in a fast-paced environment
Desired Qualifications
- ASQ Certified Quality Engineer (CQE), CRE, or equivalent certification
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