Senior Quality Engineer

Adecco; Harvard (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

401K plan

Paid leave

Job summary

Adecco is hiring a Sr Quality Engineer for a manufactur­er in Devens, MA. This direct-hire role requires strong knowledge of FDA QSR, ISO 13485, ISO 14971, and experience with design controls, risk management, and process validation.You will oversee DHF, IQ/OQ/PQ validations, CAPA and NCR handling, support audits, and partner with R&D, manufacturing, and regulatory teams during NPI and product changes in a regulated medical-device environment.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, Manufacturing Engineering, or related technical discipline; Master's preferred.
• 5-8+ years of medical device or regulated industry experience.
• Deep familiarity with FDA QSR, ISO 13485, and ISO 14971.

Responsibilities

• Oversee DHF, design verifications, and risk management files per ISO 14971.
• Lead IQ/OQ/PQ manufacturing validations, test methods, and statistical analysis (SPC, DOE).
• Manage non-conformances (NCR), CAPA, and failure investigations.
• Partner with R&D, manufacturing, and regulatory teams during new product introduction (NPI) and product changes.
• Support internal and external audits, ensuring adherence to FDA 21 CFR Part 820 regulations.

Skills

Design controls

Risk management

Process validation

Quality operations

Cross-functional collaboration

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Manufacturing Engineering

Master's degree preferred

Tools

IQ/OQ/PQ validations

SPC

DOE

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

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

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.