Medical Device Quality Assurance Manager

Who are we? We are healthcare professionals with expertise in Supply Chain, Manufacturing & Global Sourcing. We supply the nation's leading healthcare systems with medical supplies and custom procedure trays under our "Regard' brand. We also offer end-to-end supply chain solutions including logistics management and 3PL storage services.

What's in it for you?

• $90,000-150,000k annually
• relocation bonus available
• Join a growing team of health care, supply chain, manufacturing, and global sourcing professionals that are improving patient care and making communities healthier!

What will you do? 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.

• 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
• 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.
• Must be able to collaborate with various departments, friendly and professional but able to hold their ground when dealing with Operations and making decisions that may negatively impact Operations or Financials

What will you need?

• 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