Director of Quality Assurance - Active Implantables
Cirtec Medical, Brooklyn Park, Minnesota, United States
About Us
Cirtec Medical
has been a leading outsourcing partner for complex medical devices for over three decades. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.
Description Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team.
Position Summary Director of Quality Assurance manages and develops the design and manufacturing quality assurance functions for Cirtec Medical’s Active Implantables business unit. This individual builds and develops a flexible and knowledgeable team to develop and execute quality and regulatory strategies tailored to the needs of each customer across a broad risk spectrum of product categories.
Key Responsibilities
Manage and direct all areas of Quality Control and Assurance within the Active Implants business unit.
Manage Design & Development Quality and provide strategic direction and oversight for Quality Assurance of medical devices.
Ensure Design and Development programs are adequately supported for all levels of Design Control (Definition/Concept through Commercialization).
Review and contribute to key Design Control and Risk Management deliverables on development programs, such as Quality Plans, Risk Management Plans, Master Verification Plans, Master Process Validation Plans, etc.
Develop, implement, and maintain required regulatory compliance with all requisite regulatory agencies, including FDA, EU/ISO, Canadian, Asia-Pacific, and Latin America regulations.
Maintain current working knowledge of FDA and global regulatory requirements, and keep senior management apprised of new developments and potential impacts
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has been a leading outsourcing partner for complex medical devices for over three decades. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.
Description Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team.
Position Summary Director of Quality Assurance manages and develops the design and manufacturing quality assurance functions for Cirtec Medical’s Active Implantables business unit. This individual builds and develops a flexible and knowledgeable team to develop and execute quality and regulatory strategies tailored to the needs of each customer across a broad risk spectrum of product categories.
Key Responsibilities
Manage and direct all areas of Quality Control and Assurance within the Active Implants business unit.
Manage Design & Development Quality and provide strategic direction and oversight for Quality Assurance of medical devices.
Ensure Design and Development programs are adequately supported for all levels of Design Control (Definition/Concept through Commercialization).
Review and contribute to key Design Control and Risk Management deliverables on development programs, such as Quality Plans, Risk Management Plans, Master Verification Plans, Master Process Validation Plans, etc.
Develop, implement, and maintain required regulatory compliance with all requisite regulatory agencies, including FDA, EU/ISO, Canadian, Asia-Pacific, and Latin America regulations.
Maintain current working knowledge of FDA and global regulatory requirements, and keep senior management apprised of new developments and potential impacts
#J-18808-Ljbffr