Global QA Engineer – Medical Devices (ISO 13485)

OP Specialty Bracing; Greater London; On-site; GBP 45,000 - 65,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Long & Short-Term Disability

Life Insurance and AD&D

Retirement Savings Plan

Paid Time Off (PTO) & Holidays

Job summary

OP Specialty Bracing in the United Kingdom is hiring a Quality Assurance Engineer to strengthen our international QMS and support two newly acquired medical device sites. You will lead regulatory compliance efforts, audits, and process improvements across global operations.

The ideal candidate has 3+ years in medical device quality, ISO 13485 expertise, and proven ability to drive change in a fast-paced environment, with travel to multiple sites as required.

Qualifications

• 4-year degree in engineering, business, healthcare, or equivalent.
• Minimum 3 years medical device quality assurance experience.
• ISO 13485:2016 auditing and regulatory knowledge required.
• Experience with Lean/Six Sigma and process improvement.

Responsibilities

• Support ISO 13485 compliant QMS across international sites.
• Lead quality pillar for business optimization and sustainment.
• Coordinate acquisition integration quality activities and audits.
• Develop validation plans for software and manufacturing facilities.
• Drive root cause analysis, corrective/preventive actions.
• Contribute to risk management and data analysis.
• Travel to multiple international sites as needed.

Skills

QA leadership

Regulatory compliance

ISO 13485

Lean Six Sigma

Auditing

Process improvement

Cross-functional collaboration

Education

Bachelors degree in Engineering, Business, Healthcare or equivalent

Job description

OP Specialty Bracing in the United Kingdom is hiring a Quality Assurance Engineer to strengthen our international QMS and support two newly acquired medical device sites. You will lead regulatory compliance efforts, audits, and process improvements across global operations.

The ideal candidate has 3+ years in medical device quality, ISO 13485 expertise, and proven ability to drive change in a fast-paced environment, with travel to multiple sites as required.