Quality Engineer

Overview

As a Quality Engineer, you lead quality performance for a Manufacturing Value Stream, applying SPC and data-driven metrics to drive process stability and continuous improvement. You partner with manufacturing, engineering and NPI teams to embed a culture of quality excellence and informed decision-making. You’ll tackle root-cause analyses, CAPA, and risk management to ensure compliant, high-quality devices. This role offers meaningful impact across the product lifecycle with opportunities to shape processes and outcomes.

Pay / Benefits

• generous annual bonus
• pension schemes
• private health and dental plans
• flexible vacation and paid holidays
• paid volunteering hours
• hybrid working model

Responsibilities

• Act as Quality Lead for a specific Manufacturing Value Stream
• Provide day-to-day quality engineering support to manufacturing and resolve nonconformances
• Lead root cause analysis using Six Sigma and Lean tools (5 Why, Fishbone, DMAIC, 8D)
• Establish and maintain process controls, inspection plans, and quality checkpoints
• Conduct Measurement System Analysis (MSA) including Gage R&R studies
• Use statistical analysis to identify trends and recommend preventive actions
• Support change control, risk assessments, verification/validation, and documentation review
• Evaluate quality impact of product/process changes ensuring regulatory compliance
• Support readiness activities for new or updated products/processes
• Maintain risk management files (PFMEA, DFMEA, hazard analysis) across lifecycle
• Develop and execute validation plans for manufacturing processes, equipment, and inspection methods
• Perform Cp, Cpk and contribute to DOE and experimental design
• Act as subject matter expert during audits and support preparation
• Lead or contribute to CAPA with root-cause verification of effectiveness
• Ensure documentation aligns with GDP and regulatory expectations
• Collect and interpret data on quality performance (scrap, defects, yields, complaints)
• Prepare and present quality metrics to cross-functional stakeholders
• Lead Six Sigma-based CI projects focusing on yield, defect reduction and process capability
• Investigate returned products and customer complaints
• Collaborate with suppliers, test labs, and engineering to resolve issues
• Partner with Manufacturing, R&D, NPI, DQA, process engineering and QC to apply quality principles across lifecycle

Key requirements

• Bachelor’s degree in Engineering, Science, or related technical discipline
• Experience in a regulated industry (medical devices preferred)
• Experience applying Six Sigma tools (DMAIC, MSA, SPC, DOE, capability analysis)
• Experience with MSA and Gage R&R studies
• Experience with root cause analysis, validation, and risk management
• Strong analytical skills and ability to interpret technical data
• Effective communication and cross-functional collaboration skills
• Preferred Lean Six Sigma Green Belt certification
• 2–5 years of quality engineering experience in a regulated environment
• Experience with CAPA ownership and statistical data analysis
• Familiarity with design transfer and sustaining engineering processes

• Effective communication
• Cross-functional collaboration
• Problem-solving mindset
• Six Sigma (DMAIC, MSA, SPC, DOE)
• Measurement System Analysis (Gage R&R)
• Process capability analysis (Cp, Cpk)

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