Olympus Corporation of the Americas Jobs

Working Location: MASSACHUSETTS, WESTBOROUGH; NATIONWIDE

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.

Job Description

The Executive Director of Quality Process Improvement - Distribution will be responsible for establishing, maintaining, and continuously improving the Quality Management System for both Olympus distribution sites and the requirements of our third-party distributors. This role will focus on developing and implementing efficient, harmonized quality processes compliant with global regulatory requirements. In working with regional (Americas, EMEA, Japan, APAC) Distribution Quality leaders they will ensure execution of customer requirements within the boundaries of the quality processes. This role will also serve as a subject matter expert for the quality process controls needed for the distribution value stream and serve as the Global Process Owner (GPO) for the Product Ship Hold process. The Executive Director of Quality Process Improvement - Distribution will report to the VP of Global Product Distribution Quality, and work collaboratively with other functions such as Supply Chain Management (SCM), Service, Sales, Market Quality, and Regulatory Affairs to achieve organizational objectives.

Job Duties

• Develop and implement a quality management system and processes governing distribution and ensure consistent, compliant, and efficient execution.

• Serve as or manage the team accountable for Distribution quality process ownership across a global scope.

• Foster and maintain a customer-focused quality mindset throughout the organization.

• Oversee the Global Ship Hold process by collaborating with the Regional Quality, Manufacturing, Service & Repair and Corporate Field Corrective Action teams.

• Establish, track and trend metrics to ensure QMS effectiveness. Including governance and execution of the Management Review requirements for distribution.

• Lead programs to improve systems and processes to consistently meet or exceed regulatory & customer requirements.

• Drive data-driven approaches to identify areas of quality risk and customer dissatisfaction, initiate appropriate corrective actions/ preventive actions to ensure effective and timely resolution commensurate with risk.

• Assist Regional Distribution Quality leaders to ensure audit and inspection readiness.

• Provide quality and compliance expertise and guidance to Distribution and Supply Chain colleagues globally.

• Other duties as assigned.

Job Qualifications

Required:

• A BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science.

• A minimum of 12 years of experience in quality management or compliance functions within the MedTech industry. Strong understanding of Distribution requirements across global regions.

• Demonstrated comprehensive expertise in the interpretation and application of FDA regulations and other global regulations & standards governing CGMPs.

• Proven experience in designing, implementing, and improving quality systems and metrics.

• Set / deliver to global quality objectives/KPIs, reviews and assesses ongoing performance of direct reports as well as ‘dotted line’ reports (as may be required).

• Willingness to travel international up to 25-50% of the time and work outside of normal business hours to support global business operations.

Preferred:

• Advanced technical degree and MBA preferred.

• Proactive approach to quality and compliance, with a focus on innovation and adaptation in a fast-paced environment.

• Experience with LEAN/Six Sigma is preferred to drive process discipline in this global role.

• Strong ability to think and act globally, be a 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 influence key stakeholders across the business.

• Persistence to continuously improve, never settling for status quo, while keeping customer satisfaction and customer value central.

• Establish, manage, coach and develop a high performing team that meets agreed objectives on time and on budget, while delivering best practice results, added value and continuous improvement.

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.

• Competitive salaries, annual bonus and 401(k)* with company match

• Comprehensive Medical, Dental, Visions coverage effective on start date

• 24/7 Employee Assistance Program

• Free virtual live and on-demand wellness classes

• Work-life balance supportive culture with hybrid and remote roles

• 12 Paid Holidays

• Educational Assistance

• Parental Leave and Adoption Assistance

• Volunteering and charitable donation match programs

• Diversity & Inclusion Programs including Colleague Affinity Networks

• On-Site Child Daycare, Café, Fitness Center**

*US Only

**Limited locations

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 $137,913.00 - $206,869.00 / 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.

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.

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.

Applicants with Disabilities: As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at 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).

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)