Senior Director, Quality Operations, Service and Repair, Americas

Req ID: 10615

Working Location: Tennessee, Bartlett; California, San Jose

Workplace Flexibility: Hybrid

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. 

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus: https://www.olympusamerica.com/careers.

Job Description

The Executive Director of Quality Operations, Service & Repair, is responsible for building and directing a high-performing regional Quality Assurance organization, ensuring the quality management system is implemented, maintained, and continuously improved, safeguarding and improving product quality, maintaining regulatory compliance to applicable global regulations and standards, and instilling a culture of quality. Establish strategic plans and drive tactical execution to improve, standardize, and optimize quality deliverables and execution of quality and compliance objectives across regional Field Service and Repair Centers, while maintaining alignment with global strategies and supporting business growth. Define innovative solutions within the most complex and ambiguous areas of the business. Responsible for ensuring inspection readiness at all times, managing and facilitating regulatory audits and inspections, leading execution of commitments to regulators, and ensuring that quality and/or compliance issues are corrected in a timely manner. The Executive Director of Quality Operations, Service & Repair will report to the VP of Quality Management, Service and Repair, oversee repair locations throughout the Americas region including US (San Jose, CA, Bartlett, TN), Canada, Brazil and Mexico as well as the Field Service for the region, 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

Proactively lead quality in support of Service and Repair activities across the Americas region, including oversight of regional 3rd party contractors, and work with operations to ensure right first-time quality and compliance with all applicable laws and regulations.
Build, train and retain a competent quality organization. Develop and sustain a value driven, results-oriented culture and manage resources among competing departments, customers and projects.
Implement, maintain, and continuously improve quality management systems that align with globally harmonized processes and ensure consistent, compliant and efficient execution.
Anticipate and identify quality and compliance risks and proactively drive actions to mitigate. Ensure a sense of urgency commensurate with risk.
Serves as the subject matter expert for quality, advising leadership and cross-functions on complex topics and ensuring compliant execution of work.
Develop and implement regional annual Quality plans, departmental goals, and individual performance objectives in alignment with global plans.
Identify compliance gaps and drive timely and effective actions to mitigate.
In accordance with published service manuals and product risk documents, ensure implementation of effective service and repair work instructions, process controls, validation, calibration, maintenance, critical component evaluations, quality inspections, and return of product to customers.
Ensure timely and thorough investigation and resolution of quality problems (nonconformance reports, customer complaints) and effective actions to correct and mitigate recurrence (CAPA). Lead complex investigations to identify causes of problems to safeguard patient safety and business continuity.
Oversee controlled changes to products, processes, and systems.
Ensure audit and inspection readiness and successful outcomes. Ensure any observations are adequately addressed and completed on time.
Analyze product quality, compliance, and customer satisfaction data, identify trends, and collaborate with Design Assurance, Manufacturing Quality, Service & Repair and other functions to drive improvements.
Partners with senior leaders across Olympus to prioritize programs to reduce product failures and remove roadblocks to ensure delivery of an integrated approach to Quality across the business.
Engage in a positive manner with team members from all disciplines to ensure common goals are being met, lead initiatives to enhance the culture of quality and maintain a patient and customer focused quality mindset.
Other duties as assigned.

Job Qualifications

Required:

BA/BS degree or equivalent in Engineering or Physical Science (with an advanced technical degree and MBA preferred).
Minimum of 12 years Medical Device QA experience (with direct shop floor experience) in CGMP operations.
Minimum of 5 years management experience, with responsibility for direct and indirect reports. Experience operating in a matrix environment strongly preferred.
Experience with durable medical devices, and a strong understanding of installation and servicing requirements to ensure they continue to meet safety and performance specifications over their usable life.
Effective Verbal and Written Communicator.
Proactive approach to quality and compliance, with a focus on innovation and adaptation in a fast-paced environment.
Demonstrated comprehensive expertise in the interpretation and application international regulations, guidance and standards governing CGMPs.
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.
Capable of presenting clear and insightful thoughts based in facts and data gain trust, build confidence and to influence key stakeholders across the business.
Persistence to continuously improve, never settling for status quo, while keeping customer satisfaction and customer value central.
Driving cultural change in a complex and diverse Olympus organization.
Will work with global teams, availability will include working across global time zones. International and domestic travel up to 15% of the time.

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

Competitive salaries, annual bonus and 401(k)* with company match
Comprehensive medical, dental, vision coverage effective on start date
24/7 Employee Assistance Program
Free live and on-demand Wellbeing Programs
Generous Paid Vacation and Sick Time
Paid Parental Leave and Adoption Assistance*
12 Paid Holidays
On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

Work-life integrated culture that supports an employee centric mindset
Offers onsite, hybrid and field work environments
Paid volunteering and charitable donation/match programs
Employee Resource Groups
Dedicated Training Resources and Learning & Development Programs
Paid Educational Assistance

*US Only

**Center Valley, PA and Westborough, MA

Are you ready to be a part of our team?

Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.

The anticipated base pay range for this full-time position in this location is $173,449.00 - $260,174.00 / 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, including level of experience, working location, and relevant education and certifications.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, 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.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

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.

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

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 || Quality & Regulatory Affairs (QA/RA)

Nearest Major Market: San Jose
Nearest Secondary Market: Palo Alto
Job Segment: QA, Quality Assurance, Quality Manager, Inspector, Quality, Technology, Customer Service

Apply now »