Staff Engineer Quality Assurance

Job description

Work Flexibility: Hybrid The Staff Engineer – Quality Assurance Excellence provide 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, and reducing recurrence of quality issues. Partner with cross-functional stakeholders to drive systemic improvements across design, manufacturing, supplier, and post-market surveillance processes, reducing recurrence of quality issues. 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. Serves as the voice for the site (Belfast) in divisional and global meetings in the process area. Updates 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. #IJ United Kingdom Pay Ranges: United Kingdom : £42,600 - £70,900 GBP Annual At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package. If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process. Travel Percentage: 10%