Senior Quality Engineer (Hybrid) Location:Boston, MA (Hybrid - 3/2 split)

Candidates must already be locate commutable to Boston, no relocators.

Location: Boston, MA (Hybrid - 3/2 split)

Visa - &

This role is for W2 contract only

Job Description:

ACE are seeking a Quality Engineer to support the design and development of clinical and commercial Class II medical devices. This role is part of the Quality team and works closely with Product Development, Regulatory Affairs, Manufacturing, and Quality Control to ensure compliance with regulatory requirements and quality standards.

Key Responsibilities

• Ensure design control compliance and maintain Design History Files (DHF) for new product development.
• Review and approve design documentation, risk analyses (dFMEA, uFMEA, pFMEA), and verification/validation protocols.
• Support change control, impact assessments, and DHF updates.
• Investigate product complaints, lead root cause analyses, and support corrective actions.
• Evaluate product designs for manufacturability, reliability, biocompatibility, and compliance.
• Contribute to new product commercialization and continuous improvement initiatives.
• Support vendor management, audits, and documentation for product release.

Qualifications

• M.S. in Engineering with 3+ years, or B.S. with 5+ years of experience.
• 2 5 years in a regulated medical device environment; experience with combination products preferred.
• Knowledge of ISO 13485, ISO 14971, 21 CFR 820, and cGxP principles.
• Experience with DHF management, risk management, and lifecycle management.
• Strong statistical, technical writing, and communication skills.
• Ability to work independently, manage multiple projects, and collaborate effectively with cross-functional teams.

Himanshu Goswami

Sr. IT Technical Recruiter

Stellent IT Phone:

Email: Himanshu.goswami
Gtalk: Himanshu.goswamiom