ISO 13485 Lead Auditor

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 transparency
To help support our ever growing and expanding Global Audit Practice, we’re interested in speaking to Auditors who would be interested in supporting RQM on various internal audits on a contract basis for our clients in Europe.

Primary Responsibilities:

• 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. 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 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
• Must be fluent in German and English
• Robust auditing experience

Behaviours:

• Maintain the highest level of integrity
• Laser focused on customer success
• Improve all the time
• Communicate effectively and proactively
• Be courageous, proactive, and figure it out to achieve the highest level of success
• Operate as a cohesive team…. that likes to have fun
• Share concerns and follow-up with a thoughtful solution
• Lives by the Golden Rule – treat others as you would like to be treated

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.

Job Opportunity VerificationAt RQM+, we prioritize the security of our job applicants. To ensure a safe application process: All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careersEvery candidate going through the interview process will participate in a voice and/or video interview.Exercise caution with unsolicited job offers or requests for sensitive information.

This job operates in a professional office environment in a global organization. This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch, or crawl.  We are committed to promoting equality of opportunity for all staff and job applicants. We aim to create a working environment in which all individuals can make best use of their skills, free from discrimination or harassment, and in which all decisions are based on merit.