• Director, Post Market Surveillance

    Hologic (Louisville, CO)


    Director, Post Market Surveillance

     

    Louisville, CO, United States

     

    Marlborough, MA, United States

     

    Are you ready to lead a high-performing team and make a global impact in the medical device industry? At Hologic, we’re passionate about improving lives through innovative healthcare solutions, and we’re looking for a visionary leader to drive excellence and continuous product quality improvement.

     

    The Director, Post-Market Quality Engineering will lead a team responsible for driving product quality improvements, investigating complaints, and ensuring regulatory compliance. This role requires strategic leadership to enhance customer satisfaction, build strong cross-functional relationships, and foster a culture of operational excellence.

    Knowledge

    + In-depth understanding of medical device regulations: FDA 21 CFR Part 820, Part 803, ISO 13485:2016, EU MDR, and Canadian MDR.

    + Engineering principles and methodologies related to product design, manufacturing, and post-market surveillance.

    + Quality management systems and risk assessments.

    + Industry trends and advancements in medical device technology.

    Skills

    + Expertise in problem-solving and root cause analysis.

    + Strong analytical and statistical skills for trend analysis.

    + Exceptional leadership capabilities to manage and mentor teams.

    + Clear and effective communication with internal and external stakeholders.

    + Ability to handle regulatory inspections and compliance reporting.

    + Experience with Oracle & Agile tools.

    + PMP Certification.

    + Lean Six Sigma Green or Black Belt Certification.

    Behaviors

    + Proactive and results-oriented mindset.

    + Collaborative and team-focused approach to problem-solving.

    + Ability to foster an engaged, high-performing workplace culture.

    + Commitment to continuous improvement and operational excellence.

    + Independent decision-making and prioritization capabilities.

    Experience

    + Minimum **12+ years** of experience in the medical device industry or other regulated sectors.

    + Proven leadership in managing cross-functional teams and driving product quality improvements.

    + Experience in customer-facing roles and building strong relationships with stakeholders.

    + Prior management experience in complaint investigations, CAPAs, and regulatory reporting.

     

    The individual fulfilling this role must possess the physical capability to sit for extended periods, handle, or manipulate objects, tools, or controls with precision. Additionally, they should be able to stand, walk, reach with hands and arms, stoop, kneel, crouch, and be prepared to engage in domestic and international travel as required by the position.

     

    Why join Hologic?

     

    We are committed to making Hologic the destination for top talent. 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.

     

    The annualized base salary range for this role is $167,400-$297,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, 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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