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Vice President of Quality Management Repair
2 months ago
We are seeking a highly experienced and skilled Vice President of Quality Management Repair to join our team at Olympus Corporation of the Americas. This is a critical role that will oversee the Quality Assurance organizations, Quality Management Systems, and regulatory compliance for our global Repair centers.
Key Responsibilities- Quality Management: Develop and implement quality management systems to ensure compliance with regulatory requirements and industry standards.
- Regulatory Compliance: Ensure that all Repair centers are in compliance with relevant regulations and standards, including ISO, QSR, GMP, GLP, GCP, and HIPAA.
- Quality Strategy: Establish a quality strategy to improve, standardize, and optimize the quality deliverables and execution of repair quality and compliance objectives across all Repair centers globally.
- Leadership: Provide strategic direction and leadership to Regional Repair Quality leaders and ensure that they are equipped to manage and develop Quality organizations in support of Repair activities.
- Communication: Communicate effectively with cross-functional teams, including Operations, Repair, Post Market Quality, Regulatory Affairs, Medical Affairs, and others to ensure that the Quality strategy and operating objectives of the Repair Quality teams are designed in support of the company objectives and strategy.
- Education: Minimum of a Bachelor's degree in a Life Science, Engineering, or Physical Science with an advanced technical degree and MBA preferred.
- Experience: Minimum of 15 to 20 years of experience in quality management or compliance function with at least 5-7 years of management experience in a global position in a regulated environment in the MedTech industry.
- Skills: Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry, including ISO, QSR, GMP, GLP, GCP, and HIPAA. Experience with durable medical equipment and experience with Service and Repair functions within Med Tech industry is strongly preferred.
- Competitive Salary: We offer a competitive salary and bonus structure.
- Benefits: We provide a comprehensive benefits package, including medical, dental, vision coverage, 401(k) with company match, and paid time off.
- Professional Development: We offer opportunities for professional development and growth within the company.
We are committed to making people's lives healthier, safer, and more fulfilling. We are a global medical technology company that partners with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis, and minimally invasive treatment. We are dedicated to building a diverse, inclusive, and authentic workplace where our employees can fully contribute and thrive.
