Sr CAPA Quality Engineer

Here at Hologic our purpose is to enable healthier lives everywhere every dayand we do that by relentlessly improving the quality and reliability of the products our customers depend on. Were looking for a Sr CAPA Quality Engineer to be the designated owner and subject matter expert for our Corrective and Preventive Action (CAPA) system.

In this high-impact role you will lead complex highrisk CAPAs across manufacturing and quality systems ensure investigations are rigorous and datadriven and make sure actions deliver true systemic sustainable improvementsnot temporary fixes. Youll operate with a high degree of autonomy influence crossfunctional leaders and be the escalation point for CAPA quality timeliness and effectiveness. If youre passionate about root cause excellence regulatory compliance and driving meaningful measurable change this role is for you.

• Deep handson 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 riskrank 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 datadriven decisionmaking.

• CAPA Expertise
  • Proven experience owning and leading complex crossfunctional and highrisk 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.
• Root Cause & Problem Solving
  • Advanced proficiency with structured methodologies such as 5Why 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.
• Metrics & Analytics
  • 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.
• Communication & Leadership
  • 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.
• Validation & Technical
  • Proficiency in process validation (IQ/OQ/PQ) and TMV and in applying statistical analysis tools to support riskbased decisions.

• Lead with Ownership
  • Highly accountable follows through on commitments and takes responsibility when things dont go as planned.
  • Acts as the CAPA goto person and escalation point for quality timeliness and effectiveness.
• Act with Speed
  • 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.
• Foster Partnerships
  • Builds strong trustbased relationships across Operations Quality Engineering Regulatory and Supply Chain.
  • Influences without authority driving alignment and accountability across functions.
• Delight Customers & Continuous Improvement
  • Focuses on preventing recurrence and improving process robustness to protect patients and customers.
  • Uses CAPA insights to drive systemic improvements and strengthen the QMS.
• Celebrate Wins
  • Recognizes impactful CAPA successes and helps build a culture where quality improvements are visible and valued.

• Bachelors or Masters degree in Engineering Life Sciences or a related technical discipline and/or equivalent experience.
• 510 years of experience in an FDAregulated 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 crossfunctional 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.

why join Hologic

We are committed to making Hologic the company where top talent comes to grow and giving you the tools and knowledge you need to succeed in your role.

From a benefits perspective you will join our wide-ranging benefits policy including PTO Employee Stock Purchase Plans exciting Employee Wellness plans and many more.

The annualized base salary range for this role is $97600 - $152700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience skillset knowledge geography education business needs and market demand.

Agency and Third-Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

#LI-NT1