Manager, Supplier Quality Auditing

About the position

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.

Responsibilities

• Lead and conduct supplier audits focusing on technical processes to ensure compliance with applicable standards and Hologic Inc. specifications.
• Manage and follow up on supplier action plans (SACAs) resulting from the auditing/assessment program.
• Report any potential quality or regulatory issues to the Global Supplier Quality Sr. Director/Director that may affect product quality or regulatory compliance.
• Work with other Global Supplier Quality Managers to resolve supplier quality issues through effective cross-functional partnerships.
• Participate in reporting supplier quality Key Performance Indicators.
• Assist the Global Supplier Quality Sr. Director/Director as needed.
• Ensure audit supplier file records are current and well-maintained.
• Develop and maintain the annual auditing/assessment program schedule using a risk-based approach.

Requirements

• Certified Quality Auditor with accreditation from ASQ (CQA or CBA), IRCA Lead Auditor Registration, RABQSA Lead Auditor Certification, or equivalent Government Body Lead Auditor Certification.
• Bachelor's degree (BA or BS) in Biomedical, Electronics, Chemical, Mechanical, Materials Engineering, or a related field.
• Minimum of 8 years in a regulated industry such as medical devices or pharmaceuticals.
• 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.

Nice-to-haves

• Master's degree.
• ASQ Supplier Quality Engineer Certificate.
• Experience with PPAP.

Benefits

• Comprehensive training upon joining.
• Ongoing development opportunities throughout your career.
• Competitive salary and annual bonus scheme.