RQM+
Healthcare Insurance • Biotechnology • Artificial Intelligence
RQM+ is a global MedTech service provider that accelerates compliance and market success for medical device and in vitro diagnostics (IVD) companies. Offering comprehensive services throughout the product lifecycle, RQM+ specializes in regulatory and quality consulting, lab services, clinical trials, and reimbursement strategies. With a team of seasoned consultants, many of whom are former FDA and EU regulators, the company provides unmatched expertise in handling complex regulatory environments. Jordi Labs, a subsidiary, enhances the service offering with advanced materials science and chemical characterization capabilities. RQM+ utilizes innovative platforms like Fern. ai to streamline regulatory documentation and expedite market entry for life-saving medical technologies.
Lead Auditor, ISO 13485
Job not on LinkedIn
October 17
RQM+
Healthcare Insurance • Biotechnology • Artificial Intelligence
RQM+ is a global MedTech service provider that accelerates compliance and market success for medical device and in vitro diagnostics (IVD) companies. Offering comprehensive services throughout the product lifecycle, RQM+ specializes in regulatory and quality consulting, lab services, clinical trials, and reimbursement strategies. With a team of seasoned consultants, many of whom are former FDA and EU regulators, the company provides unmatched expertise in handling complex regulatory environments. Jordi Labs, a subsidiary, enhances the service offering with advanced materials science and chemical characterization capabilities. RQM+ utilizes innovative platforms like Fern. ai to streamline regulatory documentation and expedite market entry for life-saving medical technologies.
đź“‹ Description
• Responsible for project management, audit planning, executing the audit within the allotted time, issuing the audit report within the allotted time and the approval of the final audit report. • Providing the clients with 80% auditor (hats on) and 20% mentor (hats off). • Identifying and supporting the development of training modules required by the Audit Practice. • Maintaining their training in new / revised regulations, standards and guidance's as they become available. • This is a client facing role and the ideal candidate must have the quiet authority and confidence to arrange and host client meetings and conduct the audits. • As an auditor there will be challenging situations and difficult conversation with the client.
🎯 Requirements
• A professional and qualified Medical Device ISO 13485 Lead Auditor with extensive auditing experience in the Medical Device industry • Must have MDSAP auditing experience • FDA 21 CFR Part 820 experience • Robust auditing experience
🏖️ Benefits
• Industry leading compensation package • Ongoing learning and development • Work life balance
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