Quality Manager

As a Quality Manager, you will be responsible for developing and improving Quality systems in compliance with requirements through auditing, gap assessment, remediation and including management and support of Corrective/Preventive actions, Recall, Complaints etc.

Key Responsibilities

• Develop/contribute to Quality System development: ISO 13485, QSR, MDSAP, 21 CFR 820, GMP 
• Improve/remediation Quality systems through development and or revision of elements of the QMS to meet standards or new requirements Usability, ISO 13485:2016, EU MDR, GMP, safety risk management, 60601-1 3rd edition)
• Write/improve and train others on SOPs
• Perform gap assessments to prepare for external audits/FDA inspections
• Support external audits 
• Coordinate and conduct internal audits
• FDA inspection readiness and support
• Conduct EU MDR mock NB audits
• Coordinate and conduct Supplier quality audits
• Select and qualify suppliers
• Create/Maintain Authorize Supplier List (ASL) or scorecards
• Draft Supplier Agreements 
• Train others on Supplier Quality 
• Develop SOPs for Supplier Quality 

Key Requirements

• Bachelor’s Degree in relevant subject
• Experience working within medical/diagnostic device in a quality role in industry
• Working knowledge of requirements such as 21 CFR 820, ISO 13485 and GMP
• Working knowledge of standards such as: ISO 13485:2016, EU MDR, GMP, safety risk management, 60601-1 3rd edition
• FDA Regulatory requirements, the EU Medical Device
• Experience with MDSAP audits 

Being an industry leader in regulatory and quality consulting 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 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

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