Hologic, Inc. · 14 hours ago
Sr CAPA Quality Engineer
Marlborough, MA
Full-time
Onsite
Mid, Senior Level
$98K/yr - $153K/yr
5+ years expHologic, Inc. is dedicated to enabling healthier lives and is seeking a Sr CAPA Quality Engineer to lead their Corrective and Preventive Action (CAPA) system. This role involves managing high-risk CAPAs, ensuring rigorous investigations, and driving systemic improvements in quality processes.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Lead complex, high‑risk CAPAs across manufacturing and quality systems
Ensure investigations are rigorous and data‑driven
Make sure actions deliver true systemic, sustainable improvements—not temporary fixes
Operate with a high degree of autonomy and influence cross‑functional leaders
Be the escalation point for CAPA quality, timeliness, and effectiveness
Challenge weak problem statements, superficial root causes, inadequate corrective actions, and poor effectiveness checks
Define clear, executable corrective action plans with owners, timelines, and measurable success criteria
Ensure investigations identify true systemic root causes, not just symptoms or isolated failures
Ensure clear traceability from problem statement → root cause → corrective actions → effectiveness criteria
Own and manage CAPA metrics (cycle time, aging, recurrence, effectiveness)
Analyze CAPA trends to identify systemic issues and drive continuous process improvement
Provide clear updates for senior leadership and auditors
Chair or represent Quality in CAPA Review Boards, providing objective assessments and recommending escalation or strategy changes
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
Monitor CAPA execution closely and escalate stalled or ineffective CAPAs
Build strong, trust‑based relationships across Operations, Quality, Engineering, Regulatory, and Supply Chain
Influence without authority, driving alignment and accountability across functions
Focus on preventing recurrence and improving process robustness to protect patients and customers
Qualification
Required
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
Benefits
PTO
Employee Stock Purchase Plans
Exciting Employee Wellness plans
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5001-10000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (31)
2024 (20)
2023 (15)
2022 (32)
2021 (20)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.87B2025-10-21Private Equity
2025-10-21Acquired
2025-07-15Post Ipo Debt· $2.42B
Leadership Team
Stephen MacMillan
Chairman President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
2026-01-17
Company data provided by crunchbase