Quality Assurance Manager
2 days ago
The Saunders Staffing Agency is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our organization, you will be 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.
Key Responsibilities:- Oversee the Quality Management System to ensure customer and regulatory requirements are met.
- Develop and implement quality reporting and process improvement initiatives.
- Manage supplier qualification, internal audits, and CAPA management to ensure compliance with regulatory requirements.
- Establish and maintain a Quality Management System that is compliant with 21 CFR Part 820 and 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 Saunders Staffing Agency Quality System.
- Develop and implement process controls and quality controls to ensure customer and regulatory requirements are met.
- Collect, analyze, and trend quality data to provide evidence-based recommendations for process improvements.
- Supervise Quality Assurance Technicians and Quality Control Technicians.
- Education: Bachelor's degree in a science or engineering field.
- Experience: Minimum 5 years of proven experience in the medical device industry, with at least 2 years in a supervisory or management role.
This role reports to the Executive Director of Quality and Regulatory and has a team of 9 FTEs. The top 3 objectives for this position are:
- Ensure ongoing compliance with FDA requirements while improving and optimizing the quality system and transitioning to ISO 13485.
- 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.
- 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.
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