Sr. Quality Engineer, CAPA & PMO

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.

The ideal candidate is a technically capable and detail-oriented problem solver who can independently manage investigations, navigate ambiguity, prioritize competing demands, and communicate effectively across teams. This position requires strong analytical thinking, investigational rigor, and the ability to balance compliance expectations with practical business operations.

• ◆Commitment to Goals –Demonstrating a strong commitment to goals is essential for both individual and team success. This means taking clear ownership, maintaining focus on priorities, and consistently delivering high-quality results. Proactive time management, seeking support when appropriate, and overcoming obstacles are necessary to meet expectations. Aligning individual efforts with team and organizational objectives is critical to driving measurable outcomes.
• ◆Continuous Improvement - Continuous improvement involves actively identifying ways to enhance performance, skills, and contributions. Staying open to feedback, adapting to change, and applying lessons learned are required. Individual contributors are expected to seek growth opportunities and implement improvements that provide tangible value to the team and organization.
• ◆Culture and Values – Upholding our culture and values is fundamental to fostering a respectful, inclusive, and ethical work environment. Individual contributors are accountable for their actions, demonstrate respect and integrity, and consistently model behaviors that align with organizational values. Supporting an inclusive team culture and the broader organizational mission strengthens our workplace and sets a positive standard.

Principal

Corrective and Preventive Action (CAPA)

· 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.