Sr. Quality Engineer, CAPA & PMO

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.
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 Responsibilities

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.
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.

Education / Experience 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. 

Specialized Skills / Other Requirements

•    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. 

The pay range for this position at commencement of employment is expected to be between $127,000 - $190,000, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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Working Conditions / Physical Demands

TRAVEL REQUIRED: 25% Overnight domestic and/or international travel may be required.

WORKING ENVIRONMENT:
☒ Office/Professional        ☐ Plant/Manufacturing    ☐ Remote/Field     ☐ Laboratory