Working Location: PENNSYLVANIA, CENTER VALLEY

Workplace Flexibility: Hybrid

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.

**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

Job Description

The Vice President, Manufacturing Quality will organize and oversee the Quality Assurance organizations, Quality Management Systems, Quality objectives, and regulatory compliance for the global Olympus manufacturing plants. Manufacturing plants Quality leaders from all Olympus manufacturing plants will report to this position either directly or through regional multi-plant Quality leaders. 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 manufacturing Quality and compliance objectives across all manufacturing plants. The individual in this role will be responsible for managing and facilitating regulatory audits and inspections and lead execution of commitments to regulators. The individual in this role will oversee the following manufacturing locations in the US, EMEA, Japan and Rest of the World: Southend, Plymouth, Quimper, Midenmeer, Hamburg, Berlin, Prerov, Or Akiva, Cardiff, Brooklyn Park, ST. Louis, Redmond, Littleton, Bartlett, Aizu, Shirakawa, Hinode, Nagano, Aomori, Dong Nai. This role will also oversee performance indicators, quality system effectiveness, Management Review process/execution, internal audit, QMS design, external audits, supplier management, non-conformance, CAPA and other QMS elements governing manufacturing plants. The Vice President of Manufacturing Quality will work closely with other functions such as Operations, Service/Repair, Post Market Quality, Regulatory Affairs, Medical Affairs and others to ensure that the Quality strategy and operating objectives of the Manufacturing Quality teams are designed in support of the company objectives.

Primary Responsibilities: The VP, Manufacturing Quality, will focus on building and developing the following key competencies and processes: 1. Ensuring that programs to reduce product failures associated with manufacturing processes are identified, prioritized and implemented 2. Implementing programs to improve product performance through enhancement of manufacturing 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 manufacturing activities 5. Create a strong link into the Design Assurance and Service and Repair organizations to ensure consistency of test methods, repair practices and acceptance methodologies 6. Design and implement effective quality management system across manufacturing plants. 7. Develop strong and transparent KPIs to oversee and assess Quality and Compliance performance across all manufacturing plants. 8. Implement programs to reduce internal non-conformances. 9. Manage internal and external audits and inspections. 10. Improve and maintain a customer focused Quality Mindset throughout the organization

Job Duties

• Manages and develops Quality organizations in support of manufacturing plants.

• Builds and maintains Quality Management Systems for manufacturing plants.

• Manages and ensures audit readiness for internal and externa audits and inspections.

• Tracks and improves Key Quality and Compliance Process Indicators for all manufacturing plants.

• Governs and ensures through execution of the Management Review for manufacturing plants.

• Represents Quality Manufacturing leadership teams.

• Ensures disciplined execution of the Quality Systems requirements across each manufacturing plan locations.

• Works closely with R&D and Service and Repair groups to ensure consistency of processes.

• Drives Quality improvements, reduction in failures, non-conformances and recalls.

• Sets and improves Quality Culture and Mindset across all Olympus manufacturing plants.

Job Qualifications

Required:

• Bachelor's degree or equivalent in 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.

• 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:

• Experience with durable medical equipment and sterile disposable medical devices 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.

• Excellent interpersonal and leadership skills with diverse cultural approach.

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 $178,425.00 - $285,480.00 / 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) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)