Director - Quality C&V

January 21

Apply Now

Receive Emails with Similar Jobs

Integer Holdings Corporation

WebsiteLinkedInAll Job Openings

Integer Holdings Corporation is a leading provider of advanced medical device outsourcing services. With a rich history of 80 years, Integer specializes in the design, development, and manufacturing of medical devices and components. It serves major global OEMs by offering a wide range of products such as finished device systems, Class III Medical Devices, and components for cardiac rhythm management, neuromodulation, and vascular health markets. Integer is renowned for its manufacturing excellence, innovation, and commitment to enhancing patient lives through high-quality medical solutions. The company operates globally, providing unique design expertise, comprehensive product development, and strategic partnerships in the medical device industry.

Medical device outsource (MDO) manufacturer • R&D Capabilities • Transfer to Manufacturing • Manufacturing Process Oversight • Quality/Regulatory

10,000+ employees

Founded 1970

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

💰 Post-IPO Debt on 2023-01

📋 Description

• Provide strategic leadership to manufacturing site(s) to ensure compliance with quality management system policies and procedures. • Serve as a trusted advisor and partner on quality aspects. • Champion evolution of core elements of local Quality System. • Responsible for local quality management system, including CAPA, Complaint Handling, and Supplier Quality Audits. • Lead execution of enterprise quality initiatives and promote quality culture across the organization. • Interface with internal and external customers. • Ensure completion of assigned projects and manage quality-related risks. • Promote a diverse and inclusive work environment among team members. • Complete defined goals and objectives related to quality metrics.

🎯 Requirements

• Minimum education: Bachelor’s degree in a quality engineering or related technical field. • Master’s degree preferred. • ASQ Certified Quality Manager and/or Engineer preferred. • Completed Six Sigma Black Belt certification program or equivalent preferred. • Minimum 15 years of experience, including at least 10 years of management experience in healthcare or regulated manufacturing environment. • Specialized knowledge in EU MDR, ISO 13485, ISO 9001, Good Manufacturing Practices 21CFR820, and Good Documentation Practices. • Auditing experience required. • Recognized as a key resource on statistical concepts including Design of Experiments, Capability Studies, Validations, and risk assessment. • Extensive knowledge and experience in product development, design verification, validation, and risk management, coupled with in-depth Quality Management System experience. • Critical thinking and problem-solving abilities. • Demonstrated capabilities in transitioning from abstract to concrete concepts. • Awareness of Emotional Intelligence and examples of strengths as a people-developer. • Ability to thrive in a fast-paced and complex work environment and make timely decisions based on limited data. • Positive, can-do attitude with a belief that failure is not an option. • Active engagement in chosen discipline and/or related professional society. • Demonstrable skills in writing reports and business correspondence.