Lead Post Market Surveillance Specialist

Skills 

• Advanced knowledge of statistical process monitoring, signal detection, trend analysis, and surveillance methodologies (e.g., standard-deviation-based criteria, sampling per ANSI/ASQ Z1.4). 

• Demonstrated experience developing, challenging, and improving trending methodologies rather than solely executing established analyses. 

• Strong understanding of complaint handling, post market surveillance, CAPA, risk management, and regulatory requirements (e.g., 21 CFR 820, 21 CFR 803, EU MDR Article 85, UK Post-Market Surveillance Requirements). 

• Strong proficiency with statistical analysis, exploratory data analysis, data visualization, and business intelligence tools (e.g., Power BI, SQL, Tableau). 

• Ability to identify quality system gaps, establish improvement roadmaps, and lead implementation of sustainable solutions. 

• Demonstrated ability to evaluate complex quality system issues and develop practical, risk-based solutions balancing compliance, patient safety, product quality, and business objectives. 

• Strong facilitation, communication, and influencing skills; ability to communicate complex data clearly across all levels of leadership without direct authority. 

• Strong technical writing and documentation skills. 

• Ability to provide organizational leadership and strategic direction without formal supervisory responsibility. 

The annualized base salary range for this role is $116,300 - 182,000  and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.

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!

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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.