Product Quality Engineer – Medical Devices & Regulatory QA

CT19; Kidlington; On-site; GBP 50,000 - 80,000; Full time

Job summary

A growing medical imaging company in Kidlington is seeking a Product Quality Engineer to oversee quality assurance and regulatory compliance. The ideal candidate will have a degree in Science or Engineering and experience with ISO 13485 and FDA regulations. Responsibilities include managing quality control activities, supporting documentation, and collaborating with various teams to ensure product quality and compliance. This role offers an exciting opportunity to contribute to innovative 3D imaging technology.

Qualifications

• Experience in quality engineering activities for medical devices.
• Strong understanding of ISO 13485 and FDA regulations.
• Ability to manage NCRs, CAPAs, and continuous improvement initiatives.

Responsibilities

• Lead quality assurance and quality control activities.
• Oversee risk management planning and reporting.
• Collaborate with teams to maintain product quality.

Skills

Degree in Science or Engineering

Quality Management System qualification

Knowledge of product development and quality systems

Familiarity with ISO 13485 and FDA QSR

Skilled in Lean/Six Sigma methods

Excellent planning and communication skills

Education

Degree in Science or Engineering or equivalent experience

Tools

Minitab

DOE

SPC

Job description

A growing medical imaging company in Kidlington is seeking a Product Quality Engineer to oversee quality assurance and regulatory compliance. The ideal candidate will have a degree in Science or Engineering and experience with ISO 13485 and FDA regulations. Responsibilities include managing quality control activities, supporting documentation, and collaborating with various teams to ensure product quality and compliance. This role offers an exciting opportunity to contribute to innovative 3D imaging technology.