We have a current opportunity for a Quality Audit Manager on a permanent basis in Germany for a leading Medical Device manufacturer. For further information about this position please apply where we will provide further details over a phone call.
Reponsibilities
- Collaborate with the procurement department to establish the annual internal audit program and annual supplier audit program.
- Organize and execute internal audits at the company sites.
- Coordinate and conduct supplier audits in partnership with the procurement team.
- Perform ad-hoc audits internally and at supplier and subcontractor sites in response to urgent quality issues.
- Conduct process audits during critical stages of major R&D projects and post-manufacturing transfer.
- Serve as the representative for the company's internal and supplier auditing processes during customer and regulatory body audits.
- Assist in preparing for regulatory body audits.
- Schedule meetings with auditors and auditees to review audit findings and potential actions.
- Collaborate closely with the Corrective and Preventive Action (CAPA) Manager and other departments to initiate follow-up actions stemming from audits, including Non-Conformance Reports (NCRs), Root Cause Analyses, and CAPAs, and monitor deadlines.
- Develop and update Standard Operating Procedures (SOPs) and work instructions related to auditing processes.
- Provide training for co-auditors involved in internal and supplier audits.
- Regularly monitor key performance indicators (KPIs) to ensure that auditing processes operate as expected, presenting KPI reports to management on a regular basis.
- Work in conjunction with the procurement department to enhance and maintain supplier evaluation processes.
- Act as the Quality Management (QM) liaison for the company's overeseas subsidiaries, aligning the quality systems across all locations.
- Offer general support to the QM department as needed.
Requirements
- Completion of vocational education or a university degree, either in a technical field with substantial administrative experience or in a non-technical field with a strong technical understanding.
- Certification as an auditor or evidence of substantial practical experience in auditing.
- A minimum of 3 years of work experience as an internal or supplier auditor in the medical devices industry or as an auditor for a regulatory body.
- Strong knowledge and comprehension of relevant regulatory requirements, including ISO 19011, EN ISO 13485, ISO 14971, MDR, and preferably other international requirements such as FDA QSR, JPAL, and ANVISA GMP.
- Proficiency in both German and English.
- Excellent written communication skills.
- Willingness to travel approximately 20% of the time.
