Medical Device Quality Engineer - FDA/ISO Compliance (01561)

Senior Quality Engineer

Location: Devens, MA
Job Type: Direct Hire / Full-Time
Salary: $100,000, annually
Industry: Medical Device / Regulated Manufacturing

Lead Quality. Drive Compliance. Make an Impact.

Adecco is hiring a Senior Quality Engineer for a leading manufacturer in Devens, MA!

This is an exciting opportunity for an experienced Quality Engineer to take on a key role within a regulated manufacturing environment. You'll work across Quality, Engineering, R&D, Manufacturing, and Regulatory teams to ensure products and processes meet the highest standards for quality, safety, and compliance.

If you have strong experience in medical devices, FDA regulations, ISO standards, process validation, CAPA, and risk management , this could be an excellent opportunity to take the next step in your career.

What You'll Do

• Oversee Design History Files (DHF) , design verification activities, and risk management documentation in accordance with ISO 14971

• Lead and approve IQ/OQ/PQ process validations , manufacturing validations, and test method validations.

• Apply statistical tools including SPC and DOE to evaluate and improve manufacturing processes.

• Manage Non-Conformances (NCRs), CAPAs, and failure investigations from identification through resolution.

• Partner with R&D, Manufacturing, Quality, and Regulatory teams during New Product Introduction (NPI), product development, and product changes.

• Support and participate in internal and external audits

• Help ensure compliance with FDA 21 CFR Part 820 and applicable quality system requirements.

• Identify opportunities for continuous improvement and help strengthen quality processes across the organization.

• Provide technical quality support and guidance to cross-functional teams throughout the product lifecycle.

What You'll Bring

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related technical field.

• Master's degree preferred.

• 5–8+ years of experience in medical device manufacturing or another highly regulated industry.

• Strong knowledge of FDA Quality System Regulations (QSR)

• Strong understanding of ISO 13485 and ISO 14971

• Hands-on experience with process validation, risk management, CAPA, NCRs, and failure investigations

• Experience with statistical analysis and quality tools such as SPC and DOE

• Strong communication and cross-functional collaboration skills.

• Ability to effectively manage multiple projects and priorities in a regulated manufacturing environment.

Why Consider This Opportunity?

This is more than a traditional Quality Engineering role. As a Senior Quality Engineer , you'll have the opportunity to influence product quality, manufacturing processes, compliance, and continuous improvement while working alongside experienced Engineering, R&D, Manufacturing, and Regulatory professionals.

If you're ready to bring your quality expertise to a role where your work directly supports product reliability, regulatory compliance, and manufacturing excellence , apply today!

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.