Lead CAPA System Specialist

Hologic•Newark, DE

About The Position

Hologic is seeking a Lead CAPA System Specialist to be the principal expert driving excellence in our Corrective and Preventive Action (CAPA) processes. In this high-impact individual contributor role, you will partner with the QMS Manager to enhance the CAPA system, lead complex investigations and remediation efforts, and build CAPA capability across the organization. You’ll 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. If you thrive in a fast-paced, highly visible, regulated environment and want to shape how CAPA is executed across the division, this role is for you.

Requirements

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.

Nice To Haves

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.
Experience with PLM systems (e.g., Agile) for managing CAPA and quality records.

Responsibilities

Lead cross-functional CAPA activities and manage multiple CAPA workstreams simultaneously.
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.
Modify, maintain, and create procedures, tools, and training materials related to the CAPA system (CAPA “toolbox”).
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.
Ensure CAPAs are thorough, timely, and sustainable, and championing a strong quality and compliance culture.