Sr CAPA Quality Engineer

Hologic•Marlborough, MA

About The Position

Here at Hologic, our purpose is to enable healthier lives everywhere, every day—and we do that by relentlessly improving the quality and reliability of the products our customers depend on. We’re looking for a Sr CAPA Quality Engineer to be the designated owner and subject matter expert for our Corrective and Preventive Action (CAPA) system. In this high-impact role, you will lead complex, high‑risk CAPAs across manufacturing and quality systems, ensure investigations are rigorous and data‑driven, and make sure actions deliver true systemic, sustainable improvements—not temporary fixes. You’ll operate with a high degree of autonomy, influence cross‑functional leaders, and be the escalation point for CAPA quality, timeliness, and effectiveness. If you’re passionate about root cause excellence, regulatory compliance, and driving meaningful, measurable change, this role is for you.

Requirements

Deep, hands‑on understanding of CAPA regulatory expectations and best practices, including investigation rigor and effectiveness verification.
Strong working knowledge of FDA QMSR/QSR (21 CFR 820), ISO 13485, and ISO 14971, plus awareness of global regulatory requirements impacting CAPA.
Solid understanding of Quality Management Systems (QMS) and how CAPA connects to audits, complaints, nonconforming events, suppliers, and management review.
Familiarity with the key inputs to CAPA (audit findings, complaints, NCEs, supplier issues, management review outputs) and how to risk‑rank and prioritize them.
Proficiency in validation concepts, including process validation (IQ/OQ/PQ) and test method validation (TMV).
Working knowledge of statistical and analytical tools for trend analysis, CAPA metrics, and data‑driven decision‑making.
Proven experience owning and leading complex, cross‑functional, and high‑risk CAPAs from initiation through effectiveness and closure.
Ability to challenge weak problem statements, superficial root causes, inadequate corrective actions, and poor effectiveness checks.
Skilled at defining clear, executable corrective action plans with owners, timelines, and measurable success criteria.
Advanced proficiency with structured methodologies such as 5‑Why, Fishbone/Ishikawa, Fault Tree Analysis, A3, DMAIC, etc.
Ensures investigations identify true systemic root causes, not just symptoms or isolated failures.
Ensures clear traceability from problem statement → root cause → corrective actions → effectiveness criteria.
Capable of owning and managing CAPA metrics (cycle time, aging, recurrence, effectiveness).
Able to analyze CAPA trends to identify systemic issues and drive continuous process improvement.
Strong written and verbal communication skills, including clear updates for senior leadership and auditors.
Comfortable chairing or representing Quality in CAPA Review Boards, providing objective assessments and recommending escalation or strategy changes.
Able to develop and deliver CAPA training, build CAPA “toolbox” content, and coach teams on best practices.
Proficiency in process validation (IQ/OQ/PQ) and TMV, and in applying statistical analysis tools to support risk‑based decisions.
Highly accountable, follows through on commitments, and takes responsibility when things don’t go as planned.
Acts as the CAPA “go‑to” person and escalation point for quality, timeliness, and effectiveness.
Maintains a strong bias for action and urgency while keeping stakeholders informed and avoiding surprises.
Monitors CAPA execution closely and escalates stalled or ineffective CAPAs.
Builds strong, trust‑based relationships across Operations, Quality, Engineering, Regulatory, and Supply Chain.
Influences without authority, driving alignment and accountability across functions.
Focuses on preventing recurrence and improving process robustness to protect patients and customers.
Uses CAPA insights to drive systemic improvements and strengthen the QMS.
Recognizes impactful CAPA successes and helps build a culture where quality improvements are visible and valued.
Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related technical discipline, and/or equivalent experience.
5–10 years of experience in an FDA‑regulated industry, with clear, demonstrated ownership of CAPA processes.
Minimum of 3 recent years in medical devices or a similarly regulated environment.
Proven track record of leading complex, cross‑functional CAPAs stemming from audits, complaints, supplier issues, or significant quality events.
Experience supporting internal and external audits/inspections as a CAPA Subject Matter Expert, including responding to findings and driving remediation.