Quality Assurance Manager
4 weeks ago
CSI Companies is seeking a talented Quality Assurance Manager to join our client’s team onsite in Republic, Missouri. Our client is known for their expertise in Supply Chain, Manufacturing, and Global Sourcing within the healthcare sector nationwide. This role offers an opportunity to join a growing team with a mission of serving leading healthcare providers, thus improving the lives of patients and their communities.
Location: Republic, MO 65738
Hours: Full Time 40 hours/week, no weekends
Compensation: Salary ranges from $90k-$150k based on years of experience
Status: Direct Hire/Permanent
The 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 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 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.
Top 3 Objectives:
- Ensure ongoing compliance to FDA requirements while improving and optimizing the quality system and transitioning to ISO 13485.
- Ensure facility is able to deliver high quality products to customers by working with Operations to reduce in-process defects, customer complaints and recalls.
- Work to develop strong culture of Quality across all departments within the facility that will facilitate and support growth.
Minimum Qualifications:
- BA/BS in Sciences, engineering preferred
- Minimum 5 years of proven experience in the medical device industry
- Minimum 2 years of experience in a supervisory or management role
- Must be able to collaborate with various departments
Benefits Offered:
- Medical, Dental, and Vision coverage
- Voluntary Life and AD&D coverage
- Holiday & Paid Time Off
- 401K with company match
- Employee Stock Purchase Plan
- And Much More
Apply today to be placed in immediate consideration
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