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Supplier Quality Auditor Fully Bilingual German/English

BEPC Inc. - Business Excellence Professional Consulting

European Union (Remote), Sverige

  • Distans
  • Sverige
  • Engelska
  • Publicerad 18.09.26 23:30

Supplier Quality AuditorLocation: Remote – EuropeEmployment Type: Freelance/Part-Time or Full-TimeTravel: As needed for freelance assignments; approximately 60% for full-time positionsReports To: Supplier Auditing Account Manager / Division DirectorRole OverviewBEPC is seeking an experienced Supplier Quality Auditor based in Europe to support supplier quality audits for clients in the medical device and life sciences industries. This role is ideal for a seasoned auditor with extensive experience evaluating suppliers in highly regulated environments and working across international locations, cultures, and technical disciplines.The Supplier Quality Auditor will plan, coordinate, and conduct on-site and remote supplier audits throughout Europe. Audits may cover suppliers supporting medical devices, biotechnology, microbiology, sterilization sciences, and related technical areas.You will evaluate supplier quality management systems, identify compliance gaps and potential risks, document audit findings, review corrective action evidence, and prepare clear audit reports supporting client quality and regulatory objectives.Fluency in both English and German is required. Additional European language skills are highly desirable.Key ResponsibilitiesPlan, coordinate, and conduct supplier quality system audits throughout Europe.Coordinate directly with suppliers to establish audit dates and complete pre-audit planning, including travel and accommodations when required.Conduct on-site and remote/desktop audits in accordance with applicable Quality Management System (QMS) standards, regulatory requirements, and client-specific procedures.Evaluate supplier quality systems, processes, documentation, and objective evidence to identify compliance gaps and quality risks.Prepare accurate, comprehensive supplier audit reports that meet client requirements and established deadlines.Review objective evidence associated with supplier corrective actions and determine acceptability.Maintain required audit information and status updates within audit tracking systems such as EtQ.Participate in audit-related meetings with clients, suppliers, and other stakeholders as required.Build and maintain professional working relationships with suppliers and client teams across different countries and cultures.Independently manage multiple audit assignments and priorities while consistently meeting deadlines.Perform other related duties as assigned by BEPC management.QualificationsRequired QualificationsBachelor's degree in engineering, a technical discipline, or a related field.5+ years of supplier auditing experience within the medical device and/or pharmaceutical industry.Demonstrated experience conducting Quality Management System and supplier audits in highly regulated environments.Knowledge of applicable standards and regulations, including:ISO 9001ISO 13485MDSAPISO 1702521 CFR Part 82021 CFR Part 11Appropriate certification and training related to applicable regulatory and industry Quality Management System requirements.Full professional fluency in English and German, including the ability to read, write, and conduct audits in both languages.Strong knowledge of QMS auditing principles, methodologies, and techniques.Excellent written communication skills with the ability to produce professional, detailed audit reports.Strong verbal communication and interpersonal skills with the ability to work effectively with suppliers, clients, and all levels of management.Ability to work independently with minimal supervision and manage multiple complex assignments.Strong organizational skills, attention to detail, and commitment to meeting deadlines.Proficiency with Microsoft Office, including Word and Excel.Ability and willingness to travel throughout Europe as required.Preferred QualificationsCertified quality or lead auditor credentials such as ASQ CQA, ASQ CBA, ISO 9001 Lead Auditor, or ISO 13485 Lead Auditor.Fluency in one or more additional European languages.Experience auditing suppliers across technical areas such as biotechnology, microbiology, sterilization sciences, and medical device manufacturing.Experience conducting both on-site supplier audits and remote/desktop assessments.Contract DetailsLocation: Remote; candidate must be located in Europe.Work Arrangement: Audit assignments may be conducted remotely or at supplier locations throughout Europe.Schedule: Typically Monday through Friday, 8:00 a.m. to 5:00 p.m.; occasional evening or weekend availability may be required based on client and business needs.Freelance/Part-Time: Work is assigned on an as-needed basis depending on audit demand, supplier location, and auditor availability.Full-Time: Approximately 60% travel may be required to support supplier audits and business needs.Contract Dates: Not specified.Pay Rate: Not provided.About BEPCBEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive.With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.Apply Now!If you are an experienced supplier quality auditor with a strong background in medical device or pharmaceutical quality systems and are fully bilingual in English and German, we encourage you to apply.Please submit an up-to-date resume that includes specific examples of how your experience meets the qualifications above. In particular, clearly identify your supplier auditing experience, applicable QMS standards and regulations, medical device and/or pharmaceutical industry experience, auditor certifications, language proficiency, and experience conducting on-site and remote audits.USOPS