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Manager, Supplier Quality Auditing

Marlborough, MA, United States

Join Our Team as a Supplier Auditing Manager at Hologic

Hologic is seeking a committed Supplier Auditing Manager to become a vital part of our innovative team. In this role, you will manage our supplier auditing program, ensuring that our suppliers adhere to rigorous regulatory and quality standards. You will lead and guide a team of supplier auditors, and personally conduct audits to ensure our supply chain's integrity and compliance. Be a part of our mission to deliver safe and effective medical devices that enhance patient outcomes.

Key Responsibilities

+ **Audit Coordination and Execution:** Lead and conduct supplier audits focusing on technical processes to ensure compliance with applicable standards and Hologic Inc. specifications. Identify improvement opportunities throughout the production processes.

+ **Supplier Action Plans:** Manage and follow up on supplier action plans (SACAs) resulting from the auditing/assessment program.

+ **Issue Escalation:** Report any potential quality or regulatory issues to the Global Supplier Quality Sr. Director/Director that may affect product quality or regulatory compliance.

+ **Interdepartmental Collaboration:** Work with other Global Supplier Quality Managers to resolve supplier quality issues through effective cross-functional partnerships, including identifying and deploying Subject Matter Experts (SMEs) as audit team members.

+ **KPI Reporting:** Participate in reporting supplier quality Key Performance Indicators.

+ **Support Leadership:** Assist the Global Supplier Quality Sr. Director/Director as needed.

+ **Record Maintenance:** Ensure audit supplier file records are current and well-maintained.

+ **Audit Schedule Management:** Develop and maintain the annual auditing/assessment program schedule using a risk-based approach and advanced query techniques in Agile.

This role will take place in Newark, DE or Marlborough, MA

Qualifications:

+ Certified Quality Auditor with accreditation from:

+ ASQ (American Society for Quality) CQA (Certified Quality Auditor) or CBA (Certified Biomedical Auditor)

+ IRCA (International Register of Certificated Auditors) Lead Auditor Registration

+ RABQSA (Registers Accreditation Board – Quality Society of Australasia) Lead Auditor Certification

+ Equivalent Government Body Lead Auditor Certification

Education:

+ Bachelor's degree (BA or BS) in Biomedical, Electronics, Chemical, Mechanical, Materials Engineering, or a related field (required)

+ Master’s degree (desirable)

+ ASQ Supplier Quality Engineer Certificate (plus)

Experience:

+ Minimum of 8 years in a regulated industry such as medical devices or pharmaceuticals (required)

+ 4-5+ years in Quality Auditing or similar roles

+ Clean driver’s license

+ Proficient knowledge of Medical Device Regulations, In Vitro Diagnostic Regulation, cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001

+ Experience with PPAP (plus)

Skills:

+ Expertise in various validation methods and evaluation criteria

+ Advanced understanding of process transfer, materials control, change control, manufacturing processes, and product testing

+ Proficient in interpreting engineering drawings and symbols

+ Experience with risk management (pFMEAs), master validation plans, protocols, and reports (IQ, OQ, PQ)

+ Familiarity with process validation, analytical methods validation, cleaning validation, and equipment qualifications

+ Strong statistical knowledge, including SPC and acceptance sampling

+ Excellent written, verbal, and presentation communication skills

+ Familiarity with GR&R (Measurement System Analysis)

+ Proficient in Microsoft Office (Intermediate to Advanced)

+ Familiarity with Internet, Agile, and Email systems (required)

Why Join Hologic?

At Hologic, we are dedicated to fostering an environment where top talent can thrive. We provide comprehensive training upon joining and ongoing development opportunities throughout your career. We offer a competitive salary and annual bonus scheme, which will be discussed in detail by one of our talent partners. If you possess the right skills and experience, we encourage you to apply today. We look forward to hearing from you!

The annualized base salary range for this role is $119,700-199,400 and is bonus eligible. Final compensation will depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.

Agency and Third-Party Recruiter Notice:

Agencies must have a current, executed Hologic Agency Agreement to submit resumes. Agencies may only submit candidates to positions for which they have been invited 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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