Executive Director Of Quality Process Governance And Improvement - Service & Repair

Working Location: CALIFORNIA, SAN JOSE; COLORADO, GOLDEN; FLORIDA, MIAMI; MASSACHUSETTS, WALTHAM; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY; TENNESSEE, BARTLETT
Workplace Flexibility: Field
Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.
Our Purpose is to make people’s lives healthier, safer, and more fulfilling.
Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View
We deliver on our purpose and our core values by staying True to Life.

The Executive Director of Quality Process Governance and Improvement - Service & Repair will be responsible for establishing, maintaining, and continuously improving the Quality Management System for the Service & Repair organization globally. This role will focus on developing and implementing efficient, harmonized quality systems compliant with global regulatory requirements, working with regional (Americas, EMEA, Japan, APAC) Service & Repair Quality leaders to ensure right first-time execution, and establishing and monitoring metrics to optimize quality results. This role will oversee individual contributors that support development, implementation, and effective execution of the Service & Repair QMS. The Executive Director of Quality Process Governance and Improvement
Service & Repair will report to the VP of Quality Management, Service and Repair, and work collaboratively with other functions such as Operations, Service, Repair, Sales, Supply Chain, R&D/Design Assurance, Market Quality, and Regulatory Affairs to achieve organizational objectives.
Job Duties

• Oversee change management and global CAPAs within the Service & Repair organizations.
• Govern and ensure execution of the Management Review process for the Service and Repair organization.
• Establish, track and trend metrics to ensure QMS effectiveness and right first-time delivery of Service and Repair activities.
• Develop and implement quality management systems and processes governing installation, service and repair and ensure consistent, compliant, and efficient execution.
• Establish strong links with Design Assurance and Manufacturing teams to ensure consideration is given for design for serviceability, and robust technology transfer to field service and repair centers, including test methods, installation and repair procedures, and acceptance methodologies. Where special processes are used, ensure validation plans are established.
• Other duties as assigned.
• Foster and maintain a customer-focused quality mindset throughout the organization.
• Assist Regional Service and Repair Quality leaders to ensure audit and inspection readiness.
• Lead programs to improve systems and processes to consistently meet or exceed regulatory requirements and customer satisfaction. Drive data-driven approaches to identify areas of quality non-compliance and customer dissatisfaction, initiate appropriate corrective actions to ensure effective and timely resolution commensurate with risk.
• Provide quality and compliance expertise and guidance to Service and Repair colleagues globally.

Job Qualifications
Required:

• Proven experience in designing, implementing, and improving quality systems and metrics.
• Strong ability to think and act globally, be fearless change agent while managing risks, develop future visions and engage broad audiences to drive transformation.
• Persistence to continuously improve, never settling for status quo, while keeping customer satisfaction and customer value central.
• Willingness to travel international up to 50% of the time and work outside of normal business hours to support global business operations.
• Demonstrated comprehensive expertise in the interpretation and application of FDA regulations and other global regulations and standards governing CGMPs.
• Capable of presenting clear and insightful thoughts based in facts and data gain trust, build confidence and to influence key stakeholders across the business.
• A BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science. Advanced technical degree and MBA preferred.
• Proactive approach to quality and compliance, with a focus on innovation and adaptation in a fast-paced environment.
• A minimum of 12 years of experience in quality management or compliance functions within the MedTech industry. Experience with durable medical equipment and a strong understanding of Service and Repair functions within the MedTech industry.

Why join Olympus?
Here, people matter—our health, our happiness, and our lives.

• Educational Assistance
• On-Site Child Daycare, Café, Fitness Center**
• Parental Leave and Adoption Assistance
• 12 Paid Holidays
• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive Medical, Dental, Visions coverage effective on start date
• Free virtual live and on-demand wellness classes
• Diversity & Inclusion Programs including Colleague Affinity Networks
• US Only
• Limited locations
• Work-life balance supportive culture with hybrid and remote roles
• 24/7 Employee Assistance Program
• Volunteering and charitable donation match programs

We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at https://www.olympusamerica.com/careers/benefits-perks .
The anticipated base pay range for this full-time position working at this location is $135,875.00 - $203,812.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position ncluding: level of experience, working location, and relevant education and certifications.
About us:
Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .
Olympus is dedicated to building a diverse, inclusive and authentic workplace
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.
Let’s realize your potential, together.
Olympus requires all US new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || California (US-CA) || San Jose ||