Quality Assurance Manager

Job Summary

The ROI CPS, LLC Quality Assurance Manager is responsible for developing and implementing policies and procedures that support custom procedure tray manufacturing Quality System in accordance with 21 CFR Part 820 and other applicable regulations and guidance. This role is key to ensuring customer and regulatory requirements are met by establishing a strong culture of quality.

Key Responsibilities:

• Quality Management System oversight
• Quality Reporting and Process Improvement
• Supplier Qualification, Internal Audits and CAPA Management
• Establish and maintain a Quality Management System at ROi CPS, LLC that is compliant with 21 CFR Part 820. Review and approve quality system documents, reports and records.
• Ensure Quality Records are established and available, as required by 21 CFR Part 820 and the ROi CPS Quality System. Ensure electronic records and signatures comply with 21 CFR Part 11.
• Ensure adequate Process Controls and Quality Controls are defined and implemented throughout the production process to ensure customer and regulatory requirements are met.
• Collect, analyze and trend quality data. Provide quality performance data for reports and provide evidence-based recommendations for process improvements.
• Supervise Quality Assurance Technicians and Quality Control Technicians. 

What qualifications you will need:

Education

• BA/BS in sciences, engineering preferred

Experience

• Minimum 5 years of proven experience in the medical device industry
• Minimum 2 years of experience in a supervisory or management role

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