Supplier quality auditor

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 bSupplier Quality Auditor, /bbased in Brussels, Cambridge UK or Berlin, Germany.   /p pThis 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. /p pAs bSupplier Quality Auditor /b, 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. /p pbWhat to Expect: /b /p ul libConduct Supplier Audits: /b 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. /li libSupplier Action Plan Management: /b Manage and follow up on supplier action plans (SACAs) resulting from audits and assessments. /li libIssue Escalation: /b Notify and escalate any potential supplier quality or regulatory issues to the Supplier Quality Auditing Manager that could impact product quality or compliance. /li libCross-Functional Collaboration: /b 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. /li libReporting: /b Participate in reporting supplier quality Key Performance Indicators (KPIs). /li libAudit Documentation: /b Ensure supplier audit file records are accurate, up-to-date, and properly maintained. /li libAudit Scheduling: /b 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. /li libTechnical Expertise: /b Apply advanced knowledge of technical processes, materials control, and manufacturing processes to drive supplier quality improvements. /li /ul pbWhat We Expect: /b /p ul libEducation: /b Bachelor’s degree in Engineering (Biochemical, Chemical, or related field).  /li libQuality Auditor, /b 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 libExperience  /bwith master validation plans, protocols, and reports (IQ, OQ, PQ) and risk management (pFMEAs) process and documentation /li libIndustry Experience: /b2-5 years’ experience in medical device manufacturing or a related industry. /li libWorking knowledge /b of cGMP, CFR 820, ISO-13485. /li libProblem Solving:  /bKnowledgeable of problem-solving tools such as SPC, Total Quality Management, and root cause analysis. /li libStrong Communicator: /b Ability to effectively communicate at all levels of the organisation, both written and verbal. /li libAnalytical Mindset: /b Skilled at analyzing data, evaluating factors, and translating insights into actionable plans. /li libSelf-Motivated: /b Able to work independently with minimal supervision, while managing multiple complex projects. /li /ul pbWhy Hologic? /b /p ul 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 insurancebr   /li libTravel Requirements: /b 50%brbLanguage Requirements: /b Proficient in English (written and oral). A second language is a plus /li /ul p Salary: €70,000 – €86,000 gross per year /p p The final offer will depend on experience, skills, and alignment with internal pay structures. In addition, we offer a comprehensive benefits package including pension and insurances. /p p#LI-RH1 /p