Quality Assurance Specialist (Post-Market)

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.

The San Diego Campus is the center of our Diagnostics Solutions Division.  With the focus on Molecular Diagnostics, most products produced are utilized onboard innovative and fully automated sample-to-result instrument systems.  The consumables required for patient testing are integral to our business.  The business growth projections and new product development projects provide unique opportunities to enable our Purpose, Passion, and Promise to empower global health advancements.

Our Quality Assurance department is looking for a dedicated Quality Specialist to join our Post-Market Quality Assurance team. The ideal candidate plays a key role in ensuring the safety, effectiveness, and regulatory compliance of medical devices after release. The ideal candidate will be responsible for monitoring and facilitating post-market complaints, ensuring compliance with applicable industry regulations, standards, and company policy. Success in this role requires strong analytical skills, attention to detail, and effective collaboration with cross-functional teams to resolve issues and drive continuous improvement.

This is a fully onsite position based out of our San Diego campus.

Essential Duties and Responsibilities

• Complaint Handling and Investigation:
  • Receive, document, and process product complaints in compliance with Hologic SOPs and applicable regulatory requirements (FDA, ISO, EU MDR).
  • Conduct initial assessments and work with cross-functional teams (e.g., Quality Engineering, Scientist, Operations Subject Matter expert, Technical Service, R&D) to support timely investigation, root cause analysis, and resolution of complaints.
  • Ensure timely, accurate, and complete complaint records in the complaint management system.
  • Regulatory Reporting
  • Support preparation and submission of regulatory reports (e.g., FDA MDR, EU Vigilance, FSCA/FSN) according to global regulatory requirements.
  • Ensure post-market activities are compliant with Hologic’s quality system and all applicable standards
• Data Analysis & Trending:
  • Collect, review, and analyze post-market data, including product complaints, adverse events, and opportunities for improvement.
  • Identify and escalate product quality or safety signals through data trending and statistical analysis.
  • Prepare regular metrics, dashboards, and summary reports for monthly management review.
• Continuous Improvement:
  • Participate in CAPA (Corrective and Preventive Action) processes related to post-market issues.
  • Support or lead projects aimed at improving product quality, customer satisfaction, and post-market processes.
• Audit & Inspection Support:
  • Support internal and external audits related to post-market surveillance and complaint handling.
  • Maintain accurate and audit-ready documentation.
• Training & Process Development:
  • Contribute to the development and improvement of SOPs, work instructions, and training materials related to post-market quality assurance.
  • Train others as needed on complaint handling and post-market procedures.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Quality, or a related field, or equivalent experience.
• 3–5 years of experience in post-market quality assurance within the medical device industry such as medical devices, diagnostics, or pharmaceuticals).
• Knowledge of post-market surveillance, complaint handling, and regulatory reporting requirements (e.g., FDA 21 CFR 820, ISO 13485, EU MDR).
• Strong analytical and problem-solving abilities.
• Excellent written and verbal communication skills.
• Detail-oriented with strong organizational and documentation skills.
• Ability to work independently and collaboratively in a cross-functional environment

The annualized base salary range for this role is $69,000 to $102,300 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.

We offer a competitive salary and annual bonus scheme, and one of our Talent Partners would be happy to discuss this in more detail with you.

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

#LI-RF1 #Mid-level #US-Onsite

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.