Sr. Quality Engineer, CAPA & PMO
Teleflex
Summary
The Sr. Quality Engineer (CAPA and PMO) leads investigations and drives resolution of complex quality issues within the Corrective and Preventive Action (CAPA) system. This role partners cross-functionally with Quality, Manufacturing, Engineering, Operations, Supply Chain, and other business functions to identify root causes, implement sustainable corrective actions, and support continued compliance with applicable regulatory requirements.
Job description
Position Summary
The Sr. Quality Engineer (CAPA and PMO) leads investigations and drives resolution of complex quality issues within the Corrective and Preventive Action (CAPA) system. This role partners cross-functionally with Quality, Manufacturing, Engineering, Operations, Supply Chain, and other business functions to identify root causes, implement sustainable corrective actions, and support continued compliance with applicable regulatory requirements.
Principal Responsibilities
- Lead investigations and resolution activities for complex quality issues, nonconformances, deviations, complaints, audit findings, and other quality signals.
- Independently perform root cause investigations using structured problem-solving methodologies such as 8D, 5 Whys, Fishbone, Fault Tree, DMAIC, or similar tools.
- Develop, implement, and document corrective and preventive actions that address root causes and reduce the risk of recurrence.
- Ensure CAPA records are completed in accordance with internal procedures and applicable regulatory requirements, including FDA QMSR, ISO 13485, EU MDR, MDSAP, and other applicable standards.
- Collaborate with cross-functional partners to drive the timely completion of investigation activities, action items, effectiveness checks, and deliverables.
- Support evaluation of recurring issues, trend data, and quality metrics to identify potential systemic concerns and opportunities for improvement.
- Contribute to continuous improvement initiatives related to CAPA processes, investigation practices, and quality system effectiveness.
- Support preparation and participation in internal and external audits, inspections, and regulatory activities, as needed.
- Deliver CAPA training to individuals, as needed.
- Lead designated Facility Change Review Board(s) (CRB), ensuring timely assessment and prioritization of critical actions and escalation to the Executive CAPA Review Board.
- Support Executive CAPA Review Board activities, as needed.
Cross-Functional Collaboration
- Partners with Manufacturing, Engineering, Operations, Supply Chain, R&D, Regulatory Affairs, and Quality teams to support effective issue resolution.
- Communicate status, risks, and outcomes clearly to stakeholders across varying levels of the organization.
- Actively participate in cross-functional meetings, problem-solving sessions, and quality review activities.
- Provide guidance and support to team members on investigational tools, documentation expectations, and CAPA best practices, as appropriate.
Metrics, Reporting & Quality Systems
- Maintain accurate and timely documentation within electronic Quality Management Systems (eQMS).
- Support tracking and reporting of CAPA metrics, investigation status, and quality trends.
- Assist with identifying opportunities to improve CAPA cycle time, effectiveness, and compliance performance.
- Support maintenance of inspection readiness through compliant documentation and investigational practices.
Requirements
- Bachelor’s degree in Engineering, Quality, Life Sciences, or related technical discipline preferred.
- 3–5 years of experience in Quality, Manufacturing, Operations, or Regulatory functions within a regulated industry such as medical devices, pharmaceuticals, diagnostics, biotechnology, or similar.
- Minimum 2 years of direct experience managing CAPA investigations or quality system investigations.
- Experience working within quality systems compliant with FDA, ISO 13485, and/or other applicable regulatory standards.
- Experience using structured root cause analysis and problem-solving methodologies.
- Demonstrated ability to independently manage multiple priorities in a fast-paced environment.
- Strong analytical, organizational, and technical problem-solving skills.
- Ability to interpret technical, operational, and regulatory information and translate findings into actionable solutions.
- Effective written and verbal communication skills with the ability to collaborate across functions and organizational levels.
- Experience working with electronic Quality Management Systems (eQMS) and CAPA management tools preferred.
- Experience managing projects, including timeline, budget, resources, and risks preferred.
- Ability to define problems, collect and analyze data, establish facts, and draw valid conclusions.
- Comfortable working with technical documentation, engineering data, and quality system records.
- Ability to support occasional domestic and/or international travel, as required.
Benefits
- Medical, Dental & Vision
- Prescription Drug Insurance
- Flexible Spending Accounts
- 401(k) Savings Plan
- Paid Time Off
- Short-term Disability
- Long-term Disability
- Parental Leave
Company overview
Teleflex Incorporated is a global medical technology company headquartered in Wayne, Pennsylvania, that specializes in designing, developing, manufacturing, and supplying single-use medical devices for critical care and surgical applications. Founded in 1943, the company has evolved from its origins in precision mechanical controls to become a leading provider of innovative medical technologies. Teleflex serves healthcare providers in over 150 countries through a diverse portfolio that includes solutions in anesthesia, emergency medicine, interventional cardiology and radiology, surgical procedures, vascular access, and urology. The company's well-known product brands include Arrow, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck. With approximately 14,000 employees worldwide, Teleflex operates 11 manufacturing facilities and 23 distribution centers across the globe. The company focuses on purpose-driven innovation to address unmet clinical needs, aiming to improve patient outcomes, enhance provider safety, and reduce procedural costs while maintaining a strong commitment to quality and corporate social responsibility.