Senior Design Controls & QA Engineer – Medical Devices

Enhanced Compliance Inc.; Marlborough (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Enhanced Compliance Inc. in Marlborough, MA, is seeking a design controls specialist with a strong background in medical devices to lead DHF remediation and support regulatory compliance activities.

You will review design documentation, develop remediation strategies, and collaborate with cross-functional teams to reconstruct development history and provide evidence for design decisions. Strong technical writing and regulatory knowledge are essential.

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline.
• 3-5 years of experience in the medical device industry or another regulated environment.
• Working knowledge of Design Controls, Risk Management, and Product Development processes.

Responsibilities

• Participate in Design History File (DHF) remediation activities to ensure compliance with applicable design control requirements, regulatory expectations, and company procedures.
• Review and assess existing design documentation to identify gaps, inconsistencies, and opportunities for improvement.
• Develop and execute remediation strategies for design inputs, design outputs, design verification, design validation, design reviews, risk management, and traceability documentation.
• Partner with cross-functional teams to reconstruct product development history and establish objective evidence supporting design decisions.
• Author, revise, and review quality records and remediation deliverables to support audit readiness.
• Support the development and maintenance of requirements traceability matrices and design control documentation packages.

Skills

Technical writing

Regulatory compliance

Cross-functional collaboration

Analytical skills

Education

Bachelor's degree in Biomedical/Mechanical/Electrical/Quality Engineering or related technical discipline

Job description

Enhanced Compliance Inc. in Marlborough, MA, is seeking a design controls specialist with a strong background in medical devices to lead DHF remediation and support regulatory compliance activities.

You will review design documentation, develop remediation strategies, and collaborate with cross-functional teams to reconstruct development history and provide evidence for design decisions. Strong technical writing and regulatory knowledge are essential.