Global Quality Assurance Engineer - Medical Devices

Boston Brace International, Inc dba OP Specialty Bracing; United Kingdom; 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 is seeking a Quality Assurance Engineer to support ISO 13485:2016 compliance across international sites, including two UK manufacturing facilities. You will lead audits, drive process improvements, and mentor teams in Lean/Six Sigma while coordinating with global stakeholders.

The role requires a 4-year degree in Engineering/Healthcare or related fields, 3+ years in medical device QA, and robust knowledge of regulatory frameworks (FDA, EU MDR).

Qualifications

• 4-year degree in Engineering, Business, Healthcare or equivalent.
• Minimum 3 years medical device QA experience or healthcare quality assurance.
• Experience with Lean/Six Sigma and process improvement.
• Auditing and regulatory compliance knowledge (ISO 13485, FDA, EU MDR).

Responsibilities

• Support ISO 13485:2016 compliant quality system across international sites.
• Lead audits of suppliers, contract manufacturers, and distributors.
• Develop and execute validation plans (IQ/OQ/PQ) and risk management activities.
• Drive root cause analysis, corrective/preventive actions, and data analysis.
• Coach and mentor teams to sustain high product quality and efficiency.

Skills

Quality mgmt

Leadership

Cross-functional

Lean Six Sigma

Regulatory knowledge

Auditing

Education

4-year degree (Engineering/Healthcare)

Tools

ISO 13485 auditing

Job description

OP Specialty Bracing is seeking a Quality Assurance Engineer to support ISO 13485:2016 compliance across international sites, including two UK manufacturing facilities. You will lead audits, drive process improvements, and mentor teams in Lean/Six Sigma while coordinating with global stakeholders.

The role requires a 4-year degree in Engineering/Healthcare or related fields, 3+ years in medical device QA, and robust knowledge of regulatory frameworks (FDA, EU MDR).