Senior Quality Engineer

Adecco; Chelmsford (MA); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Short-term disability

Commuter benefits

401K plan

Employee Assistance Program (EAP)

Job summary

Adecco is hiring a Sr Quality Engineer for a medical device manufacturer in Devens, MA. This direct hire role offers a salary range of $100,000 to $120,000 annually.

The successful candidate will oversee design controls, risk management, and regulatory compliance, and lead validation activities across IQ/OQ/PQ, SPC/DOE analyses. Responsibilities include managing NCRs, CAPA, and investigations; cross-functional leadership with R&D, manufacturing, and regulatory teams during new product

Qualifications

• Deep familiarity with FDA Quality System Regulations (QSR) and ISO 13485.
• Knowledge of ISO 14971 risk management.
• Experience with design controls, IQ/OQ/PQ, and CAPA processes.

Responsibilities

• Oversee Design History Files (DHF) and design verifications per ISO 14971.
• Lead and approve IQ/OQ/PQ manufacturing validations, test methods, and SPC/DOE analyses.
• Manage non-conformances (NCR), CAPA, and failure investigations.
• Collaborate with R&D, manufacturing, and regulatory teams on NPI and product changes.
• Support FDA inspections and ensure compliance with FDA 21 CFR Part 820.

Skills

Quality Engineering

Regulatory compliance

Statistical analysis

Education

Bachelor’s degree in Mechanical/Biomedical/Manufacturing Engineering or related

Master's degree preferred

Job description

Adecco is hiring for a Sr Quality Engineer for a manufacturer in Devens! This is a direct hire position.

Salary range: $100,000 - $120,000 annually

Key Responsibilities

• Design Controls & Risk: Oversee Design History Files (DHF), design verifications, and risk management files per ISO 14971.

• Process Validation: Lead and approve IQ/OQ/PQ manufacturing validations, test methods, and statistical analysis (SPC, DOE).

• Quality Operations: Manage non-conformances (NCR), Corrective and Preventive Actions (CAPA), and failure investigations.

• Cross-Functional Leadership: Partner with R&D, manufacturing, and regulatory teams during new product introduction (NPI) and product changes.

• Auditing & Compliance: Support internal and external audits, ensuring adherence to FDA 21 CFR Part 820 regulations.

Qualifications & Requirements

• Education: Bachelor’s degree in Mechanical, Biomedical, Manufacturing Engineering, or a related technical discipline (Master's preferred).

• Experience: 5–8+ years of medical device or regulated industry experience.

• Core Knowledge: Deep familiarity with FDA Quality System Regulations (QSR), ISO 13485, and ISO 14971.

Pay Details: $100,000.00 to $120,000.00 per year

• medical
• dental
• vision
• life insurance
• short-term disability
• additional voluntary benefits
• EAP program
• commuter benefits
• 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

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.