Senior Quality Engineer - Medical Devices, FDA/ISO Expert

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

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.