Quality Engineer

Michael Page; Weston (MA); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits package

Opportunities for growth

Job summary

A leading recruitment agency is seeking a Quality Engineer in Weston, MA. This role involves ensuring compliance with medical-device regulations and overseeing quality systems. Key responsibilities include conducting audits, root cause analysis, and collaborating with teams to improve manufacturing processes. The ideal candidate will have 1-2 years of experience in quality engineering for medical devices, strong knowledge of FDA regulations, and excellent problem-solving skills. Competitive salary offered between $90,000 and $110,000 annually, along with a comprehensive benefits package.

Qualifications

• 1-2 years of experience as a Quality Engineer for implantable medical device products.
• Expertise in ISO 13485:2016 and ISO 14971.

Responsibilities

• Develop and implement quality assurance processes for compliance.
• Conduct root cause analysis and corrective actions for quality issues.
• Collaborate with cross-functional teams to optimize manufacturing.

Skills

ISO 13485 knowledge

FDA 21 CFR Part 820 knowledge

Analytical skills

Problem-solving skills

Communication abilities

Detail-oriented

Risk management skills

Education

Bachelor's degree in Engineering or related field

Tools

FMEA

Statistical analysis software

Job description

This role serves as the U.S.-based quality and regulatory lead, ensuring full compliance with medical‑device regulations while overseeing quality systems, supplier performance, and imported product controls. It supports audits, design transfer, CAPA, inspections, and end‑to‑end oversight of global manufacturing partners to maintain product safety, documentation accuracy, and regulatory readiness.

This organization develops advanced, patient‑specific medical solutions using cutting‑edge engineering, modeling, and manufacturing technologies. It focuses on highly customized products designed to improve clinical outcomes through precision, innovation, and individualized treatment approaches. The company operates across global partner locations, integrating design, quality oversight, and production capabilities to support regulated medical‑device markets.

Description

• Develop and implement quality assurance processes to ensure compliance with industry standards.
• Conduct root cause analysis and implement corrective actions to address quality issues.
• Collaborate with cross‑functional teams to optimize manufacturing processes.
• Monitor and analyze production data to identify trends and areas for improvement.
• Conduct audits and inspections to ensure adherence to quality standards.
• Prepare detailed reports on quality performance and present findings to stakeholders.
• Support the development and maintenance of quality documentation and procedures.
• Train team members on quality standards and best practices.

Profile

A successful Quality Engineer should have:

• 1–2 years of experience as a Quality Engineer for implantable medical device products.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and other relevant medical device regulations.
• Experience with FDA inspections: QSIT inspection preparation, 483 response, and Warning Letter remediation.
• Expertise in ISO 13485:2016, ISO 14971, and MDSAP requirements.
• Excellent analytical and problem‑solving skills.
• Effective communication and collaboration abilities.
• Detail‑oriented with a strong commitment to quality and continuous improvement.

Job Offer

• Competitive salary ranging from $90,000 to $110,000 USD annually.
• Comprehensive benefits package.
• Opportunities for growth within the medical device industry.
• A supportive and professional work environment.

If you are ready to take on the role of Quality Engineer, we encourage you to apply today!

Desired Skills and Experience

• Experience with ISO 13485, FDA 21 CFR Part 820, and global medical‑device regulatory compliance.
• Hands‑on involvement with FDA inspections, QSIT prep, 483 responses, and foreign facility oversight.
• Strong skills in risk management (ISO 14971), statistical analysis, and root‑cause tools like FMEA, 5‑Why, Fishbone, and 8D.
• Experience managing supplier quality across domestic and international partners, including audits and quality agreements.
• Ability to review and maintain DHF/DMR/DHR, support design transfer, and assess regulatory impact of design changes.
• Background in post‑market surveillance, CAPA leadership, inspection protocols, and batch‑record review for imported devices.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.