What are the responsibilities and job description for the Quality Engineer II_Local Preferred_W2 Only position at Ace Technologies?
Location :Marlborough,MA
Duration :12 months
Job Summary:
Seeking a Quality Engineer II to support new product development, manufacturing transfer, validation, and commercial operations in a regulated biotech/bioprocessing environment.
Key Responsibilities:
- Support Design Controls, Risk Management, FMEA, and design/process verification.
- Maintain Design History Files and support NPI and product commercialization.
- Review and approve IQ/OQ/PQ, deviations, nonconformances, and CAPAs.
- Manage change controls, customer complaints, root cause analysis, and corrective actions.
- Drive process validation, quality compliance, and continuous improvement using Lean/Six Sigma.
Required Qualifications:
- Bachelor’s degree in Engineering, Biological Science, Physical Science, or related field.
- 5 years of Quality Engineering experience in an ISO 9001 or regulated environment.
- Experience in New Product Development Quality Engineering.
- Experience with biotech hardware, consumables, and manufacturing processes.
- Working knowledge of cell culture, filtration, and chromatography in bioprocessing.
- Internal auditing experience; ASQ CQE/CRE certification preferred.
- Strong problem-solving, communication, and cross-functional collaboration skills.
Salary : $32 - $34