CAPA Process Lead

Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day.

We are hiring a CAPA Process Lead in our Diagnostics division here in San Diego. In this role and under our QA function, you will actively drive Corrective and Preventive Actions (CAPA), from issue identification to implementation of solutions, and verification of effectiveness. The incumbent will manage all aspects of applicable CAPA activity, which includes aligning with cross functional stakeholders, facilitating CAPA team meetings, and ensuring CAPA deliverables per project timelines, and maintaining and reporting on the process to leadership. 

This is a fully onsite role in San Diego, CA.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the following responsibilities as required by business needs.  

• Leads with ownership of CAPA activities and projects, by applying project management principles to planning, investigating, executing, measuring and closing CAPAs in a cross functional environment. 
• Acts with speed, utilizing Risk-based principles to align with key stakeholders and drive decisions.
• Fosters partnerships, communicating effectively with interdepartmental teams and stakeholders to develop and implement quality plans, procedures, and protocols. 
• Delights customers by collecting input from internal stakeholders and conducting statistical analysis of quality data to identify and implement continuous improvement projects and solutions that drive value for the business. 
• Ensures the robustness and integrity of CAPA records and source documentation (Nonconformances, Trend Reports, etc.) 
• Represents CAPA activities during audits and CAPA Review Board meetings. 
• Supports the logistics, delivery, and maintenance of CAPA training across multiple levels. 
• Collaborate with internal partners to maintain relationships and communicate quality expectations.
• Provides status updates to appropriate personnel at all levels, including management, peers, and key stakeholders.
• Serves as a mentor on Quality principles to employees across all levels.
• Demonstrates tactical leadership capabilities, as needed, to support management.
• Maintains detailed knowledge of relevant quality system regulations (e.g., 21 CFR Parts 806 and 820, ISO 13485, and ISO 14971).
• Contributes to a culture of continuous improvement through process improvement activities.
• This position requires full on-site presence in San Diego, CA, five days a week.

Required Education and Experience:

• Bachelor of Science with at least 8 years of Quality experience with a strong emphasis in Quality Systems, Risk Management, Root Cause Analysis and CAPA.
• ASQ Certification (CQA, CQE) is preferred.
• Project Management Professional (PMP) certification is strongly preferred.
• Experience with Regulatory Inspections is required.
• Advanced understanding of 21 CFR Part 806, 820, ISO 14971 and ISO 13485.
• Advanced understanding of quality engineering principles including risk management, nonconformance and CAPA, root cause investigation, trend analysis, statistical methods, and acceptance sampling.
• Experience utilizing Project Management Principles.
• Must be capable of providing presentations across all levels.
• Must possess impactful project management and leadership skills, with demonstrated experience leading cross functional project teams consisting of all levels and effectively addressing quality-related issues.

The annualized base salary range for this role is $104,800 to $174,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.

Why Hologic?

We are committed to making Hologic the company where top talent comes to grow. 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.

If you have the right skills and experience, apply today!

#LI-RF1 #lead-level

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 Department. In 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.