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

Additional Information

Reports to Executive Director Quality and Regulatory

FTE's- 9

Top 3 Objectives

1. Ensure ongoing compliance with FDA requirements while improving and optimizing the quality system and transitioning to ISO 13485

2. Ensure the facility is able to deliver high-quality products to customers by working with Operations to reduce in-process defects, customer complaints, and recalls

3. Work to develop a strong culture of Quality across all departments within the facility that will facilitate and support growth

Compensation: Salary ranges from $75- 90K based on years of experience

Relocation on a case-by-case basis