Senior Med Device QA Engineer – CAPA, ISO 13485

Stryker; Belfast City District; On-site; GBP 37,000 - 61,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

Stryker Corporation in the United Kingdom is seeking a Senior Engineer, Quality Assurance for a fixed-term contract until 31 August 2028. Based onsite in Belfast, you will establish, improve, and maintain the quality system, providing quality engineering support across operations and business functions.

You will drive CAPA, NCR closures, change control, risk management, audits, and continuous improvement initiatives while collaborating with internal and external teams to ensure compliant,

Qualifications

• 2+ years’ experience in a Quality or Regulatory Affairs role; prior industry experience desirable.
• Proficient understanding of Med Device manufacturing, ISO 13485, GMP.
• Excellent communication skills with attention to detail.
• Strong knowledge of Risk Management, CAPA, Audits and Statistics.
• Fluent in written and spoken English; able to operate in a multi-site team.

Responsibilities

• Collaborate with operations to ensure quality performance of products and processes.
• Manage internal and supplier NCs, ensuring timely investigation and closure.
• Own CAPAs through root cause analysis to closure.
• Review change management activities and drive effectiveness.
• Support audits and field actions with QA input.
• Lead Lean initiatives to standardize and remove waste.

Skills

Quality Assurance

CAPA/NCR

Root Cause Analysis

Lean Six Sigma

GMP ISO13485

Communication skills

Risk Management

Education

Honours Bachelor’s Degree

EU EQF Level 6

QA/Regulatory experience

Lean Six Sigma training

Tools

Microsoft Word

Microsoft Excel

PowerPoint

MSA methods

Regulatory databases

Job description

Stryker Corporation in the United Kingdom is seeking a Senior Engineer, Quality Assurance for a fixed-term contract until 31 August 2028. Based onsite in Belfast, you will establish, improve, and maintain the quality system, providing quality engineering support across operations and business functions.

You will drive CAPA, NCR closures, change control, risk management, audits, and continuous improvement initiatives while collaborating with internal and external teams to ensure compliant,