Are you looking for a Senior Compliance Auditor opportunity where you can be part of a growing industry? Well regarded company in the medical device industry needs a dynamic Senior Compliance Auditor to join a growing team in Plymouth, MN. This 12 month contract position offers growth and the potential to get extended
Responsibilities of Senior Compliance Auditor:
• Responsible to perform Corporate audits across sites. Conduct audits, according to Site risk levels identified, independent of local Site Management, as per SM Policy. Ensure that the SM Quality Manual, Policies, Procedures and Global Work Instructions have been implemented at Sites. Ensure audit is conducted based on the risk to patients through product and process risk evaluation, and risk to the site and/or Smiths Medical divisionally through compliance assessment. The purpose of the program of Corporate Audits is to identify compliance issues so that these can be attended to before they become the subject of external Regulatory concerns, and to promote and share ‘best practice’ across all Sites.
• Perform, as a lead auditor, corporate audits according to schedule, for the various sites globally.
• Perform peer review of audit reports in a timely manner, ensuring clear communication and consistent content across reports written by the team.
• Perform post-audit follow up of non-conformances written, including timely review of investigation, corrective action plan, and all necessary closure documents.
• Assist sites with preparation to transition to new regulatory requirements (example ISO 13458:2016, EU MDR).
• Maintain professional certification as Lead Auditor, and knowledge in applicable regulations/standards.
• Lead project teams through investigation and preparation of government agency responses (ex: FDA 483 Responses). • Facilitate and prepare presentations for government agency meetings (ex: FDA, Health Canada).
REQUIREMENTS of Senior Compliance Auditor:
• University Degree (BA degree) required.
• Four (4) years minimum of direct experience in Medical Device Quality or Compliance (multi-site Medical Device organization experience preferred).
• Strong working knowledge of current international and company regulatory compliance requirements and operating procedures, including (but not limited to) FDA, ISO 13485, MDSAP, European Medical Device Directive and Medical Device Regulation, and applicable industry Standards.
• Demonstrated proficiency at critically reviewing quality documentation and records (e.g. procedures and completed records).
• Demonstrated proficiency in technical writing and development of standard operating procedures.
• Effective facilitation skills to lead discussions around audit findings, driving to consensus and resolution of identified non-conformances.
DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace. We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be. Apply today and experience “The DAVIS Difference”.