At a Glance
- Tasks: Lead quality assurance initiatives and drive improvements in product safety and compliance.
- Company: Join a leading medical technology company committed to innovation and patient safety.
- Benefits: Competitive salary, hybrid work model, and comprehensive benefits package.
- Other info: Opportunity for mentorship and growth in a collaborative team setting.
- Why this job: Make a real impact on patient safety while developing your career in a dynamic environment.
- Qualifications: Degree in science or engineering with experience in quality assurance and risk management.
The predicted salary is between 42600 - 70900 £ per year.
The Staff Engineer – Quality Assurance Excellence provides senior technical leadership in quality engineering, driving complex investigations, risk management activities, and post-market safety initiatives across products and processes. Lead high-impact root cause analyses for field performance issues, nonconformances, and emerging quality signals to protect patient safety and ensure global regulatory compliance. Apply risk-based thinking to assess impact, drive effective corrective and preventive actions, and implement continuous improvements.
Collaborate cross-functionally to strengthen design, manufacturing, and post-market processes, reducing recurrence of quality issues. Partner with cross-functional stakeholders to drive systemic improvements across design, manufacturing, supplier, and post-market surveillance processes. The position partners cross-functionally to drive robust investigations, risk management, and regulatory compliance in alignment with FDA (21 CFR Part 820/QMSR), ISO 13485, and ISO 14971 requirements, while ensuring field actions are executed efficiently, safely, and in accordance with company standards and global regulatory expectations.
Essential duties & responsibilities:
- Establish and maintain standardized process and procedure for executing field action assessments and executions, including but not limited to investigations and identifying solutions.
- Lead and provide strategic direction to Senior Quality Assurance Engineers responsible for Product Field Action Assessments (PFAA), Non-Conformance (NC), and CAPA activities.
- Lead Product Field Action monthly Board review.
- Develop strategies and plans for field actions in alignment with organizational goals and objectives.
- Ensure alignment with current regulatory standards, including 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and applicable global regulations.
- Identify potential risks associated with field action decisions and implement measures to mitigate them effectively.
- Serve as the escalation point for complex investigations, risk evaluations, and cross-functional decision-making.
- Monitor key performance indicators (KPIs) to evaluate the effectiveness of the field action process and implement improvements as necessary.
- Mentor and coach Senior QA Engineers and broader teams on risk management principles, investigation rigor, and PFA expectations.
- Collaborate with internal stakeholders, such as PFA assessment and execution owners, engineers, and technicians, to ensure seamless coordination and communication regarding field action deliverables.
- Maintain a customer-centric approach by ensuring that field actions are completed promptly and meet or exceed customer expectations.
- Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and safety of field action decisions over time.
- Support internal and external audit activities relating to the PFA process.
- Serve as the voice for the site (Belfast) in divisional and global meetings in the process area.
- Update key stakeholders and leaders on divisional record deliverables and progress.
Qualifications & experience:
- Minimum requirements:
- BS in a science, engineering or related discipline.
- Minimum of 4 years demonstrated PFA experience is preferred.
- Post-Market Quality, and Product Field action experience preferred.
- Experience leading complex investigations and applying root cause analysis methodologies (e.g., 8D, FTA).
- Experience with statistical analysis and risk-based methodologies.
- Preferred qualifications:
- CQE (certified quality engineer), or equivalent.
- Six Sigma Green or Black belt desired.
- Ability to build trusting relationships with all levels of management.
- Ability to generate and explain detailed assessments, execution plans, and any potential challenges accurately.
Travel Percentage: 10%
Staff Engineer Quality Assurance in Belfast employer: Stryker
As a Senior Manager in Procare Services, you will join a dynamic and innovative team dedicated to transforming service delivery into a key driver of commercial success. Our company fosters a collaborative work culture that prioritises employee growth through continuous development opportunities and cross-functional partnerships, all while operating in a diverse and cross-cultural environment across the UK and Northern Europe. With a strong focus on performance metrics and customer outcomes, we offer a rewarding career path for those looking to make a meaningful impact in the healthcare technology sector.
