Senior Quality Engineer - Medical Devices, ISO 13485, QSR

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 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.