Lead Supplier Quality Auditor

Lead Supplier Quality Auditor

Location: South Korea, Taiwan or Dubai 

Are you passionate about ensuring the highest standards of quality and regulatory compliance in a dynamic environment? Do you excel at building strong supplier relationships and driving continuous improvement? If so, we have an exciting opportunity for you to join our team as a Lead Supplier Quality Auditor,. 

This is your chance to contribute to impactful work in the medical device industry, where your expertise will directly support our mission of improving lives through innovation and quality.

As Lead Supplier Quality Auditor, you will be an integral part of our dynamic team. You will directly contribute to the success of our supplier auditing program by conducting audits to ensure suppliers meet strict regulatory and quality standards. Your work will play a vital role in maintaining the integrity and compliance of our supply chain.

What to Expect:

• Conduct Supplier Audits: Execute audits across APAC (focusing on technical processes) to suppliers as part of the audit program, ensuring compliance with applicable standards, regulations, and Hologic specifications. Review production processes to identify improvement opportunities.
• Supplier Action Plan Management: Manage and follow up on supplier corrective action plans resulting from audits and assessments.
• Issue Escalation: Notify and escalate any potential supplier quality or regulatory issues to the Supplier Quality Auditing Manager that could impact product quality or compliance.
• Cross-Functional Collaboration: Work with other Supplier Quality Auditors/Engineers and cross-functional teams to troubleshoot and resolve supplier quality issues. Identify Subject Matter Experts (SMEs) for audit teams as needed.
• Reporting: Participate in reporting supplier quality Key Performance Indicators (KPIs).
• Audit Documentation: Ensure supplier audit file records are accurate, up-to-date, and properly maintained.
• Audit Scheduling: Participate on the development and maintenance of the annual audit/assessment program schedule using a risk-based approach, including assessing controls and determining appropriate audit frequency.
• Technical Expertise: Apply advanced knowledge of technical processes, materials control, and manufacturing processes to drive supplier quality improvements.

What We Expect:

• Education: Bachelor’s degree in Engineering (Biochemical, Chemical, or related field). An ASQ SQE or CQA certification is preferred.
• Active ISO 13485 Auditor certification from a globally recognized credentialing body like Exemplar, ASQ, CQI/IRCA, or similar. 
• Experience with master validation plans, protocols, and reports (IQ, OQ, PQ) and risk management (pFMEAs) process and documentation
• Industry Experience: 8+ years’ experience in medical device manufacturing or a related industry, with 5+ years in a Quality Auditing function preferred.
• Working knowledge of Medical Device Regulations/In Vitro Diagnostic Regulation, cGMP, CFR 820, ISO-13485 (Required).
• Strong Communicator: Ability to effectively communicate at all levels of the organization, both written and verbal.
• Analytical Mindset: Skilled at analyzing data, evaluating factors, and translating insights into actionable plans.
• Self-Motivated: Able to work independently with minimal supervision, while managing multiple complex projects.

Why Hologic?

• Work on impactful projects that make a difference in the medical device industry.
• Build relationships with suppliers around the globe, develop your skills and grow your career in a supportive and collaborative environment.
  Travel Requirements: 50 - 60%
  Language Requirements: Proficient in English (written and oral). A second language is a plus

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