Auditor Consultant- Ex-FDA Experience

Posted 3 Days Ago
Hiring Remotely in United States
Remote
Entry level
Healthtech
The Role
RQM+ is looking for Auditors with experience in various regulatory and quality fields to support supplier/vendor audits in the EU and U.S. This role will involve a mix of on-site and remote desktop audits. The company values client support, employee satisfaction, industry compensation packages, and work-life balance.
Summary Generated by Built In

RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines in Healthcare products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. In addition to early- and mid-stage MedTech companies, we currently work with 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.



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 supplier/vendor 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.


We’re interested in speaking to Auditors with a background in any of the following fields:


· ISO 13485:2016

· EU MDR

· 21 CFR 820

· 21 CFR Part 4

· 21 CFR Part 11

· Quality System Gap analysis

· Mergers & Acquisition Audits

· Mock FDA Inspection

· MDSAP

· IVD

· EU IVDR

· ISO 9001:2015

· ISO 17025

· ISO 14971

· ISO 60601

· ISO 62366

· ISO 62304

· ISO 10993

· Sterilisation

· Pre-Clinical

· Clinical

· ICH Q7 Requirements

· ICH Q10 Requirements

· 21 CFR 210/211

Being an industry leader in client support is just the beginning for RQM+. Providing a rewarding place to work is rooted deep in the core values of RQM+. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ applies the “and means more” approach to employment. At RQM+, you are not just another employee, you are a member of the RQM+ family. Make your impact today! We invite you to submit an application if you have an interest in learning more about our organization and beginning your journey as a consultant with us. We require willingness to work a flexible schedule and travel at least 25% of the time Job Opportunity Verification At 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/careers Every 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.


Being an industry leader in client support is just the beginning for RQM+. Providing a rewarding place to work is rooted deep in the core values of RQM+. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ applies the “and means more” approach to employment. At RQM+, you are not just another employee, you are a member of the RQM+ family. Make your impact today! 


We invite you to submit an application if you have an interest in learning more about our organization and beginning your journey as a consultant with us. 


We require willingness to work a flexible schedule and travel at least 25% of the time 


Job Opportunity Verification

At 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/careers

Every 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.



Top Skills

Cfr
Iso
Mdr
The Company
Monroeville, PA
508 Employees
On-site Workplace

What We Do

RQM+ is the world’s leading provider of regulatory, clinical and quality solutions to the MedTech industry. We deliver transformative solutions to customers by providing unrivaled collective knowledge and expertise, fueled by our passion for customer success. Our experts are collaborative, laser-focused on customer needs, and committed to delivering high-value solutions for both medical devices and diagnostics that exceed expectations.

Learn more about our services, free resources, and more at www.RQMplus.com

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