Hologic, Inc. · 20 hours ago
Lead CAPA System Specialist
Newark, DE
Full-time
Hybrid
Senior Level, Lead/Staff
$107K/yr - $168K/yr
8+ years expHologic, Inc. is seeking a Lead CAPA System Specialist to drive excellence in their Corrective and Preventive Action (CAPA) processes. The role involves enhancing the CAPA system, leading investigations, and building CAPA capability across the organization while applying deep QMS and CAPA expertise.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Drive excellence in Corrective and Preventive Action (CAPA) processes
Partner with the QMS Manager to enhance the CAPA system
Lead complex investigations and remediation efforts
Build CAPA capability across the organization
Apply deep QMS and CAPA expertise, advanced problem-solving skills, and strong cross-functional influence to resolve complex quality issues and ensure sustainable, compliant solutions
Develop, maintain, and communicate CAPA metrics, dashboards, and reports to monitor process health and drive continuous improvement
Author CAPA records, procedures, remediation plans, and regulatory documentation
Support or lead internal and external audit workstreams as a CAPA Subject Matter Expert (SME)
Mentor and coach junior staff in CAPA and quality system fundamentals, building organizational capability
Qualification
Required
Deep end-to-end understanding of CAPA processes: intake, risk/escalation assessment, investigation, root cause analysis, action planning, implementation, and effectiveness checks
Strong working knowledge of FDA 21 CFR 820 and ISO 13485, with emphasis on CAPA, nonconformance management, complaints, and management review
Broad understanding of Quality Management Systems (QMS) and how CAPA connects to other processes (e.g., audits, NCs, field actions, PMQA)
Familiarity with global quality regulations and expectations regarding CAPA in audits and inspections (e.g., FDA, Notified Bodies)
Proven ability to lead cross-functional CAPA activities and manage multiple CAPA workstreams simultaneously
Expert in CAPA methodologies, including root cause analysis techniques, effectiveness verification, and design of sustainable corrective actions
Strong analytical and problem-solving skills to interpret complex quality data, identify systemic risks, and prioritize improvement opportunities
Ability to develop, maintain, and communicate CAPA metrics, dashboards, and reports to monitor process health and drive continuous improvement
Excellent technical writing skills for authoring CAPA records, procedures, remediation plans, and regulatory documentation
Strong written and verbal communication skills, including clear executive-level updates and presentations to director-level leadership
Capable of modifying, maintaining, and creating procedures, tools, and training materials related to the CAPA system (CAPA “toolbox”)
Experience supporting or leading internal and external audit workstreams as a CAPA Subject Matter Expert (SME)
Models Hologic's quality values, promoting defect prevention, reduction of variation and waste, and a culture of continuous improvement
Operates with a high degree of independence, using sound judgment in selecting methods and techniques to solve complex problems
Highly organized, able to manage complex, multi-threaded remediation efforts and CAPA programs in a fast-paced environment
Proactive, adaptable, and comfortable in a high-visibility role with competing priorities and tight timelines
Collaborative and influential, working effectively with junior staff, peers, and leaders across QMS, Operations, R&D, Supply Chain, and other functions
Mentors and coaches junior staff in CAPA and quality system fundamentals, building organizational capability
Promotes accountability and ownership, ensuring CAPAs are thorough, timely, and sustainable, and championing a strong quality and compliance culture
Technical Bachelor's Degree required (e.g., Engineering, Quality, Life Sciences, or related technical discipline)
8+ years of relevant experience with a Technical Bachelor's degree, or 6+ years with a Master's degree in a technical or engineering-related field
Significant experience leading CAPAs and remediation efforts in a regulated environment, ideally in the medical device industry
Experience supporting remediation in response to audits, inspections, or enforcement actions and/or driving continuous improvement initiatives
Demonstrated experience acting as a CAPA SME in internal and external audits and inspections
Preferred
Experience with Agile or equivalent Product Lifecycle Management (PLM) systems
Understanding of statistics and basic statistical analysis for CAPA metrics, trend analysis, and risk evaluation
Master's degree preferred
Beneficial: Experience with PLM systems (e.g., Agile) for managing CAPA and quality records
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
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