Medical Device QA Engineer — Regulatory & CAPA Lead

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

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.