• Principal Supplier Quality Auditor

    Hologic (Marlborough, MA)


    Principal Supplier Quality Auditor

     

    Newark, DE, United States

     

    Marlborough, MA, United States

     

    Are you passionate about ensuring compliance, driving supplier quality improvements, and making an impact in the medical device industry? Hologic is seeking a **Principal** **Supplier Quality Auditor** to play a critical role in maintaining the integrity and regulatory compliance of our supply chain. In this role, you’ll conduct supplier audits, manage supplier action plans, and collaborate with cross-functional teams to uphold the highest quality standards.Join us in our mission to deliver safe and effective medical devices that improve patient outcomes.

    Knowledge

    + Expertise in supplier auditing processes, including compliance with regulatory standards (cGMP, CFR 820, ISO 13485).

    + In-depth knowledge of medical device and/or pharmaceutical regulations, including risk management processes (e.g., pFMEAs) and validation protocols (IQ, OQ, PQ).

    + Familiarity with supplier action plans (SACAs), root cause analysis, and technical manufacturing processes.

    + Strong understanding of SPC, GR&R (Measurement System Analysis), and acceptance sampling.

    + Knowledge of PPAP (Production Part Approval Process) and global regulatory frameworks (FDA, Canada, Brazil, Japan, etc.).

    Skills

    + Strong communication abilities across all organizational levels, both written and verbal.

    + Analytical problem-solving skills to evaluate data, identify improvement opportunities, and develop actionable solutions.

    + Proficiency in Microsoft Office Suite, statistical analysis tools, SPC, and acceptance sampling methods.

    + Ability to lead audits independently, demonstrating agility and adaptability in complex scenarios.

    + Multilingual capabilities (English required, additional language desirable).

    Behaviors

    + A proactive approach to identifying and resolving supplier quality issues.

    + Collaborative mindset, working seamlessly with cross-functional teams and subject matter experts.

    + Commitment to maintaining accurate, up-to-date audit documentation and supplier quality metrics.

    + Passion for continuous improvement, driving supplier compliance and innovation.

    Experience

    + 8+ years in regulated industries (medical devices, pharma) with 5+ years of quality auditing experience.

    + Accredited certifications such asRABQSA Lead Auditor Certification,ASQ Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), or IRCA Lead Auditor Registration is a must.

    + Familiarity with validation protocols, root cause analysis, GR&R, PPAP, and global regulations (FDA, Canada, Brazil, Japan, etc.).

    + Bachelor’s degree in Biomedical, Electronics, Chemical, Mechanical, or Materials Engineering (Master’s degree desirable).

     

    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 $114,800-179,500 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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