Senior Quality Engineer - Medical Devices, Design Controls

Planet Pharma; Woburn (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading medical device company is seeking a Quality Engineer to provide engineering support for design control and risk management processes. The ideal candidate will have a BS in STEM and over 5 years of experience in Quality Engineering specifically within the Medical Device sector. Responsibilities include ensuring compliance with global regulations, generating quality deliverables, and leading quality improvement efforts. Strong communication skills and familiarity with data analysis tools like Minitab are essential for success in this role.

Qualifications

• 5+ years of Quality Engineering experience in the Medical Device industry.
• Competency with the 21 CFR, 820, and Medical Device Directive.
• Familiarity with EU MDR regulations.

Responsibilities

• Serve as Quality Engineering representative ensuring compliance with regulations.
• Generate compliant completion of Quality deliverables.
• Lead CAPA and quality improvement efforts.

Skills

Quality Engineering Experience

Regulatory Compliance Knowledge

Data Analysis

Communication Skills

Education

BS in STEM

Tools

Microsoft Office Suite

Minitab

Job description

A leading medical device company is seeking a Quality Engineer to provide engineering support for design control and risk management processes. The ideal candidate will have a BS in STEM and over 5 years of experience in Quality Engineering specifically within the Medical Device sector. Responsibilities include ensuring compliance with global regulations, generating quality deliverables, and leading quality improvement efforts. Strong communication skills and familiarity with data analysis tools like Minitab are essential for success in this role.