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Vice President of Quality Management and Compliance
2 months ago
Job Summary
The Vice President of Quality Management and Compliance will oversee the development and implementation of quality management systems, ensuring compliance with regulatory requirements and industry standards. This role will lead the global quality assurance team, driving strategic direction and improving quality deliverables across all repair centers.
Key Responsibilities
- Develop and implement quality management systems, ensuring compliance with regulatory requirements and industry standards.
- Lead the global quality assurance team, driving strategic direction and improving quality deliverables.
- Oversee the development and implementation of quality objectives, key performance indicators, and management review processes.
- Ensure audit and inspection readiness for all repair facilities, governing and executing the management review process.
- Represent quality on repair organization leadership teams, working closely with R&D and operations groups to ensure consistency of processes.
- Drive improvement in repair quality, reduction in failures, non-conformances, and related field actions.
Requirements
- 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.
- Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry.
- Experience with durable medical equipment and experience with service and repair functions within the MedTech industry is strongly preferred.
- Initiative in innovative approaches to quality and compliance in a fast-paced changing business environment.
- Excellent written and oral communication and organizational, project management skills.
- Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence.
Preferred Qualifications
- Excellent interpersonal and leadership skills with diverse cultural approach.
- A self-starter motivated and able to positively motivate others. Demonstrates the highest ethical standards, actively promotes trust, respect, and integrity in all dealings both inside and outside the organization.
- Focused, target-driven with a positive, can-do attitude and a desire to improve patient experience as well as company performance.
About Olympus
Olympus is a global medical technology company committed to making people's lives healthier, safer, and more fulfilling. We partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis, and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
Our Culture
We recognize diversity in people, views, and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
