RQM+ is
The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better.We don’t make MedTech. We make MedTech happen.Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success.
RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparencyTo help support our ever growing and expanding Global Audit Practice, we’re interested in speaking to Ex-FDA Inspectors who would be interested in supporting RQM on various FDA mock audits on a contract basis for our clients in the EU and U.S.
These will be a mixture of on-site and remote desktop audits.
Primary Responsibilities:
- The candidate will have previously worked as a Medical Device Inspector for the US Food & Drug Administration (FDA), within the past 10 years (2015-2025) and with a minimum of 5 years’ experience as an Inspector
- The candidate will be expected to travel globally to conduct onsite audits
- The candidate will work with the RQM+ project team to coordinate the audit schedule
- The candidate will work with the RQM+ project team to support the 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
- The candidate will be capable of providing the clients with 80% auditor (hats on) and 20% mentor (hats off)
- The candidate will be responsible for identifying opportunities where RQM+ can provide additional support and assistance to the client. These opportunities shall be fed back to the RQM+ project team
- The candidate will be responsible for maintaining their training in new / revised regulations, standards and guidance’s as they become available
- This is a client facing role and the 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 conversations with the client
- When appropriate the candidate will escalate the challenging situation to the RQM+ project team
- The candidate must have the strength of character to manage these situations with tact, diplomacy and integrity. Admit when they are wrong and maintain their position when they are right
Requirements:
- A former US FDA Medical Device Inspector (within the past 10 years, 2015-2025) with a minimum of 5 years’ experience as an FDA Inspector
- Expertise in Quality System Inspection Technique (QSIT)
- Expertise in ISO13485:2016, MDSAP audit techniques highly desirable
- Expertise in EU MDR / EU IVDR audit techniques an advantage
- Robust auditing experience
- Communicate effectively and proactively
- A university degree or equivalent in science or nursing
Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.
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