Quality Compliance Specialist
3 weeks ago
This role involves performing audits to support the Becton, Dickinson and Company Quality Audit program. As a Quality Compliance Specialist, you will be responsible for conducting quality internal audits of various locations' Quality management systems in the EMEA region and others as directed by the Associate Director, Quality & Regulatory Compliance, Quality Audits.
About the RoleYou will be responsible for ensuring compliance with domestic and international medical device standards and regulations, local procedures, and corporate policies/procedures through conducting quality audits. This includes following up with auditees to compile information related to the audits, evaluating the adequacy of provided evidence against the approved Audit Action Plan (AAP), and maintaining the audit system software database to record the status of all audits and associated actions.
Duties and Responsibilities- Conduct quality audits to ensure compliance with relevant standards and regulations.
- Follow up with auditees to gather information and compile findings.
- Evaluate evidence against the Audit Action Plan.
- Maintain the audit database to track audit statuses and associated actions.
- Provide periodic reports to management on audit statuses and metrics.
To be successful in this role, you will require:
- Certified Quality Auditor/ISO Lead Auditor Certification or equivalent.
- Certified Quality Engineer.
- Certified Manager of Quality / Organizational Excellence.
- Minimum 3 years of work experience in the quality organization of a medical device and/or pharmaceutical company.
- Experience with warning letters and other regulatory actions is preferred.
We offer a competitive salary and a range of employee benefits, including flexible benefits and opportunities for professional development.
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