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.
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rqmplus.com/careers
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