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Quality Assurance Specialist 1

San Diego, CA, United States

Here at Hologic it is our purpose to enable healthier lives everywhere, every day. We are driven by our passion to become the global champion for women’s health. We achieve this by fulfilling our promise to bring The Science of Sure to life.

The **Post Market Quality Assurance (QA)** team plays a critical role in safeguarding patient safety and ensuring regulatory compliance across global markets for Hologic Molecular Diagnostic products.

Think this role is for you?

As a **Quality Assurance Specialist 1** under the Post-Market QA team, you will play a key role in ensuring the safety, effectiveness, and regulatory compliance of medical devices after release.

You 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 of limited complexity and drive continuous improvement.

Key Outcomes

+ **Complaint handling and investigation**

+ Receive, document, and process product complaints in compliance with applicable regulatory requirements and company standard operating procedures (SOPs).

+ Conduct initial assessment of complaints.

+ **Regulatory reporting**

+ Identify and escalate potential adverse events to QA management.

+ Support preparation and submission of regulatory reports according to global regulatory requirements under supervision of Senior QA Specialists or management.

+ Ensure post-market activities are compliant.

+ **Data analysis and trending**

+ Assist with complaint metrics and basic trend analysis.

+ Perform complaint-related queries as needed.

+ **Audit and inspection support**

+ Support internal and external audits related to post-market surveillance and complaint handling as needed.

+ Maintain accurate and audit-ready documentation.

+ **Training and process development**

+ Contribute to the development and improvement of SOPs, and other materials related to post-market quality assurance under the supervision of Senior QA Specialists or management.

Do you have what it takes?

+ You are a good communicator, have impeccable attention to detail, and strong organizational and documentation skills.

+ You work well in a cross-functional team environment, can work independently, and have a proactive mindset.

+ You have strong analytical and problem-solving skills and are comfortable presenting data.

Additional qualifications and information

+ Bachelor’s degree in Engineering, Quality, Life Sciences, or related field, or equivalent experience.

+ 0-2 years of experience in post-market quality assurance within the medical device industry is highly preferred.

+ Knowledge of post-market surveillance, complaint handling, and regulatory reporting requirements (e.g., ISO 13485, FDA 21, CFR 820, EU, MDR).

+ Certification in Quality or Regulatory (ASQ, RAPS) is a plus

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The annualized base salary range for this role is $70,500 - $71,000 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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