Lead CAPA Quality Engineer

Hologic Careers • Newark, DE

2d • $119,300 - $186,600

About The Position

Hologic is looking for a Lead CAPA Quality Engineer to play a key role in strengthening quality and compliance across our global supply chain. In this senior, hands-on role, you will lead and facilitate Corrective and Preventive Actions (CAPAs), advise on risk and escalation decisions, and partner closely with manufacturing and supply chain teams to resolve complex issues. You’ll apply deep QMS knowledge, strong problem-solving skills, and cross-functional influence to prevent recurrence of issues, reduce variation and waste, and support a culture of continuous improvement. If you enjoy tackling diverse quality challenges, collaborating across functions, and owning CAPAs from issue identification through effective closure, this role is for you.
Knowledge
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.
Beneficial: Experience with Agile or equivalent Product Lifecycle Management (PLM) system for quality and CAPA records.
Skills
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.
Behaviors
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.

Requirements

• 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.
• Experience working with CAPA programs and QMS elements in a regulated or manufacturing environment strongly preferred.
• 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.

Nice To Haves

• Experience with Agile or equivalent Product Lifecycle Management (PLM) system for quality and CAPA records.
• Experience supporting or participating in internal and external quality audits is beneficial.
• Experience with Agile or similar PLM systems is a plus.

Benefits

• We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees