Job Description

The Vice President of Quality Management Repair will organize and oversee the Quality Assurance organizations, Quality Management Systems, Quality objectives, and regulatory compliance for the global Olympus Repair centers.

Regional Repair Quality leaders will report directly to this position.

The individual in this role will be providing strategic direction and will 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.

The individual in this role will be responsible for overseeing, managing and facilitating regulatory audits and inspections and lead execution of commitments to regulators.

The individual in this role will oversee the repair locations throughout the Americas (including Latin American and Canada), EMEA, Japan, China, and other Asia Pacific countries.

The following roles will report into this role directly: Executive Director, Repair Quality (Americas), Executive Director, Repair (EMEA), Executive Director, Repair (Asia), Executive Director, Repair Process Governance.

This role will also oversee performance indicators, quality system effectiveness, Management Review, internal audit, QMS design and execution, external audits, supplier management, non-conformance, CAPA and other QMS elements governing Service and Repair centers.

The Vice President of Quality Management, Repair will work closely with other functions such as 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.

Primary Responsibilities

The VP of Quality Management, Repair, will focus on building and developing the following key competencies and processes:

1. Ensuring that programs to reduce product failures associated with repair are identified, prioritized and implemented
2. Implementing programs to improve product performance through enhancement of repair processes.
3. Drive data driven approach to identify areas of Quality, Compliance and Customer dissatisfaction
4. Improving Efficiency of Quality organization and processes in support of Repair activities
5. Create a strong link into the Design Assurance and Manufacturing organizations to ensure consistency of test methods, repair practices and acceptance methodologies
6. Change control and CAPA processes
7. Improve and maintain a customer focused Quality Mindset throughout the organization

Job Duties

Principle Duties and Responsibilities

• Manages and develops Quality organizations in support of Repair activities.
• Builds and maintains Quality Management Systems across all Repair sites.
• Ensures consistent execution of Repair objectives.
• Tracks and improves Key Process Indicators for Repair organizations.
• Ensures audit and inspection readiness for all Repair facilities.
• Governs and ensures through execution of the Management Review for Repair organization.
• Represents Quality on Repair organization leadership teams.
• Ensures disciplined execution of the Quality Systems requirements across each location.
• Works closely with R&D and Operations groups to ensure consistency of processes.
• Drives improvement in repair quality, reduction in failures, non-conformances and related field actions.

Job Qualifications

Required:

• Minimum requirements are a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree and MBA preferred.
• 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 such as: ISO, QSR, GMP, GLP, GCP, HIPAA.
• Demonstrated expertise in the design, implementation and measurement of quality systems and metrics.
• Experience with durable medical equipment and experience with Service and Repair functions within Med Tech 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.
• "Out of box" strategic thinker with strong leadership ability.
• As a change agent, motivated to improve organization and not be satisfied with status quo.
• Experienced in initiating, cultivating and embedding a cultural change in a complex and diverse Olympus organization.
• Other Considerations (travel/hours availability, etc.): Since this is a Global role, the individual will be expected to schedule meetings that work for multiple time zones and well as up to 50% travel should be expected.

Preferred:

⦁ 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 Olympus.
⦁ Focused, target driven with a positive, can-do attitude and a desire to improve patient experience as well as company performance.
⦁ Excellent writing and verbal skills.