Quality Assurance Engineer

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Quality Assurance Engineer

Newark, DE, United States

Marlborough, MA, United States

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Hologic is seeking a Quality Assurance Engineer to support and strengthen Corrective and Preventive Action, CAPA, processes and broader quality assurance operations. This role will partner closely with Quality Management System, QMS, leadership and cross-functional teams to improve CAPA performance, support remediation efforts, build CAPA competency, and help sustain effective quality systems.

The ideal candidate brings strong experience in quality assurance within a regulated environment, particularly medical device, IVD, or pharmaceutical, and has demonstrated expertise in CAPA, root cause analysis, quality metrics, audit support, and continuous improvement.

Key Responsibilities CAPA System Leadership and Support

• Serve as a subject matter expert for CAPA, including root cause analysis, effectiveness checks, and sustainable corrective actions.
• Coordinate and facilitate CAPA Review Board meetings and related documentation.
• Own and improve the divisional CAPA toolbox, including training materials, templates, and reference resources.
• Monitor CAPA system health, conduct daily reviews for escalations, and coordinate with departments to support adequate resourcing.
• Provide input into global CAPA process improvements and related training content.

Quality Assurance Operations

• Support and model Hologic's quality values while promoting a culture of accountability, compliance, and continuous improvement.
• Collaborate with junior staff, peers, and cross-functional stakeholders across multiple organizational levels.
• Assist in the development, implementation, and maintenance of quality assurance procedures, processes, and documentation.
• Proactively identify opportunities to strengthen QMS processes, including inputs to and outputs from CAPAs.
• Analyze quality data and trends to identify improvement opportunities and systemic risks.
• Develop and maintain CAPA and quality metrics, dashboards, and reporting tools.
• Routinely partner with internal suppliers and stakeholders to review CAPA data, monitoring, and performance.

Audit and Compliance Support

• Participate in and support internal and external audits, including FDA inspections, as a CAPA and quality systems subject matter expert.
• Assist with audit preparation, data collection, and communication with functional areas to support audit readiness and efficiency.
• Help ensure compliance with applicable FDA regulations, QMSR, ISO 13485, and other relevant global quality standards.

Training and Mentorship

• Mentor and coach junior team members in CAPA and quality system fundamentals.
• Provide consultation and training on CAPA principles, methodologies, and best practices to QMS and cross-functional teams.

Continuous Improvement and Special Projects

• Lead or contribute to CAPA-related remediation projects and continuous improvement initiatives.
• Support data analysis activities to develop key performance indicators across functions.
• Review open Quality Plans, QPLs, and provide recommendations for updates or improvements.

Qualifications Education

• Technical Bachelor's degree or higher preferred.

Experience

• 3-8 years of experience in the medical device, IVD, or pharmaceutical industry, with increasing responsibility in quality assurance and CAPA systems.
• Experience with Agile or an equivalent Product Lifecycle Management system is beneficial.

Skills and Knowledge

• Strong working knowledge of QMSR, ISO 13485, and global quality regulations.
• Demonstrated ability to lead cross-functional teams and manage multiple workstreams.
• Excellent technical writing, analytical, and problem-solving skills.
• Strong interpersonal and communication skills, including the ability to provide executive-level updates and support regulatory documentation.
• Detail-oriented, highly organized, proactive, and comfortable working in a dynamic environment.
• Ability to present materials to director-level leadership.
• Understanding of statistics and statistical analysis.

So why join 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. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

If you have the right skills and experience and want to join our team, apply today. We can't wait to hear from you!

The annualized base salary range for this role is $97,600 - $152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

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.

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