Senior Quality Engineer

Adecco Portugal; Harvard (MA); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Short-term disability

401K plan

Job summary

Adecco is hiring a Senior Quality Engineer for a leading medical device manufacturer in Devens, MA. You will work across Quality, Engineering, R&D, Manufacturing, and Regulatory teams to ensure products meet quality, safety, and compliance standards.

You’ll bring 5–8+ years in medical device manufacturing, with hands-on experience in FDA QSR, ISO 13485, and ISO 14971, plus process validation, CAPA, NCRs, and risk management. Strong collaboration and communication are essential.

Qualifications

• Bachelor’s degree in Mechanical, Biomedical or Manufacturing Engineering or related field.
• 5–8+ years of experience in medical device manufacturing or regulated industry.
• Strong knowledge of FDA QSR and ISO standards.
• Hands-on experience with process validation, risk management and CAPA.
• Experience with SPC and DOE for quality improvements.
• Excellent cross-functional collaboration and communication.

Responsibilities

• Oversee DHF, design verification and risk management per ISO 14971.
• Lead IQ/OQ/PQ validations and manufacturing validations.
• Apply SPC and DOE to improve processes.
• Manage NCRs, CAPAs and failure investigations.
• Partner with R&D, Manufacturing, Quality and Regulatory for NPI and changes.
• Support internal and external audits.
• Ensure compliance with FDA 21 CFR Part 820.
• Identify opportunities for continuous improvement across the organization.
• Provide technical quality support across the product lifecycle.

Skills

DHF oversight

IQ/OQ/PQ validations

SPC analysis

DOE methods

CAPA management

NCR handling

Regulatory liaison

FDA QSR

ISO 13485

ISO 14971

Education

Bachelor's degree in Engineering

Master's degree preferred

Tools

Statistical software

Job description

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.

Pay Details: $100,000.00 per year

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

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy

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.