PAre 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 strongSupplier Quality Auditor, /strongbased in Brussels. /ppThis 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. /ppAs strongSupplier Quality Auditor /strong, 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. /ppstrongWhat to Expect: /strong /ppstrongConduct Supplier Audits: /strong Execute audits (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. /ppstrongSupplier Action Plan Management: /strong Manage and follow up on supplier action plans (SACAs) resulting from audits and assessments. /ppstrongIssue Escalation: /strong Notify and escalate any potential supplier quality or regulatory issues to the Supplier Quality Auditing Manager that could impact product quality or compliance. /ppstrongCross-Functional Collaboration: /strong 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. /ppstrongReporting: /strong Participate in reporting supplier quality Key Performance Indicators (KPIs). /ppstrongAudit Documentation: /strong Ensure supplier audit file records are accurate, up-to-date, and properly maintained. /ppstrongAudit Scheduling: /strong 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. /ppstrongTechnical Expertise: /strong Apply advanced knowledge of technical processes, materials control, and manufacturing processes to drive supplier quality improvements. /p pstrongWhat We Expect: /strong /ppstrongQualifications Knowledge: /strong /pul listrongEducation: /strong Bachelor’s degree in Engineering (Biochemical, Chemical, or related field). An ASQ Supplier Quality Engineer Certificate is a plus. /li listrongQuality Auditor, /strong with an accreditation record Certifications. Required accreditation from one of the following: ASQ (American Society for Quality) CQA (Certified Quality Auditor) or CBA (Certified Biomedical Auditor), IRCA (International Register of Certificated Auditors) Lead Auditor Registration, RABQSA Lead Auditor Certification or equivalent government body certification. /li listrongExperience /strongwith master validation plans, protocols, and reports (IQ, OQ, PQ) and risk management (pFMEAs) process and documentation /li listrongIndustry Experience: /strong 7+ years’ experience in medical device manufacturing or a related industry, with 5+ years in a Quality Auditing function preferred. /li listrongWorking knowledge /strong of Medical Device Regulations/In Vitro Diagnostic Regulation, cGMP, CFR 820, ISO-13485 (Required). /li listrongProblem Solving: /strongProficiency with problem-solving tools such as SPC, Total Quality Management, and root cause analysis. /li listrongStrong Communicator: /strong Ability to effectively communicate at all levels of the organisation, both written and verbal. /li listrongAnalytical Mindset: /strong Skilled at analyzing data, evaluating factors, and translating insights into actionable plans. /li listrongSelf-Motivated: /strong Able to work independently with minimal supervision, while managing multiple complex projects. /li /ulpstrongWhy Hologic? /strong /pul liWork on impactful projects that make a difference in the medical device industry. /li liBuild relationships with suppliers around the globe, develop your skills and grow your career in a supportive and collaborative environment. /li liCompetitive salary and benefits package, including health insurance /li /ulpbr /strongTravel Requirements: /strong 50%br /strongLanguage Requirements: /strong Proficient in English (written and oral). A second language is a plus. /pp#LI-HE1 /p