Hologic, Inc. · 12 hours ago
Lead CAPA Quality Engineer
Newark, DE
Full-time
Onsite
Senior Level, Lead/Staff
$119K/yr - $187K/yr
5+ years expHologic, Inc. is looking for a Lead CAPA Quality Engineer to play a key role in strengthening quality and compliance across their global supply chain. In this senior, hands-on role, you will lead CAPA efforts and collaborate with various teams to resolve quality challenges and improve processes.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Lead and facilitate Corrective and Preventive Actions (CAPAs)
Advise on risk and escalation decisions
Partner closely with manufacturing and supply chain teams to resolve complex issues
Apply deep QMS knowledge, strong problem-solving skills, and cross-functional influence to prevent recurrence of issues
Reduce variation and waste
Support a culture of continuous improvement
Manage, facilitate, and participate in CAPA programs for complex, cross-functional issues
Provide guidance on CAPA process flow—from risk/escalation assessment through post-closure effectiveness checks
Review data sources, trending issues, and determine when escalation to CAPA is required
Represent global supply chain CAPAs during CAPA Review Board meetings and quality forums
Draft, modify, and maintain procedures and processes related to CAPA, NCEs, and supply chain quality
Support internal and external audits, including front-room/back-room support, preparation, and documentation follow-up
Collect, analyze, and present data for trending and key performance indicators (KPIs) related to CAPA and quality performance
Develop and deliver CAPA awareness and training materials to increase organizational capability
Qualification
Required
Deep understanding of Quality Management Systems (QMS) and CAPA processes, including risk/escalation assessment, root cause documentation, corrective action planning, and effectiveness verification
Working knowledge of manufacturing and global supply chain operations and how they interface with quality processes
Familiarity with nonconformance (NCE) inputs and other quality signal sources that feed escalation and CAPA
Understanding of quality system elements such as Management Review, divisional CAPA Review Boards, internal/external audits, and regulatory expectations
Proven ability to manage, facilitate, and participate in CAPA programs for complex, cross-functional issues
Skilled at providing guidance on CAPA process flow—from risk/escalation assessment through post-closure effectiveness checks
Strong analytical skills for reviewing data sources, trending issues, and determining when escalation to CAPA is required
Excellent communication and collaboration skills to work with various levels of employees, peers, and cross-functional teams across the organization
Ability to represent global supply chain CAPAs during CAPA Review Board meetings and quality forums
Capable of drafting, modifying, and maintaining procedures and processes related to CAPA, NCEs, and supply chain quality
Experience supporting internal and external audits, including front-room/back-room support, preparation, and documentation follow-up
Ability to collect, analyze, and present data for trending and key performance indicators (KPIs) related to CAPA and quality performance
Able to develop and deliver CAPA awareness and training materials to increase organizational capability
Models Hologic's quality values and supports others in applying BSH quality system requirements and standards
Strong sense of ownership and accountability—takes issues from identification through to robust, sustainable closure
Highly collaborative and influential, able to work effectively across departments and at multiple organizational levels without direct authority
Detail-oriented and organized, capable of managing multiple CAPAs, audit actions, and projects simultaneously
Proactive, self-directed professional who requires little day-to-day instruction and uses sound judgment in selecting methods and techniques
Continuous improvement mindset—actively identifies opportunities to enhance processes, reduce variation and waste, and improve overall quality performance
College degree required; Technical Bachelor's degree preferred (e.g., Engineering, Quality, or related technical field). 8+ years of relevant experience with a non-technical college degree, 5+ years of relevant experience with a Technical Bachelor's degree, or 3+ years of relevant experience with a Master's degree
Preferred
Experience with Agile or equivalent Product Lifecycle Management (PLM) system for quality and CAPA records
Experience working with CAPA programs and QMS elements in a regulated or manufacturing environment strongly preferred
Experience supporting or participating in internal and external quality audits is beneficial
Experience with Agile or similar PLM systems is a plus
Benefits
Comprehensive training
Continued development and training
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
2026-01-08
Company data provided by crunchbase