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Site Quality Systems Director

Req ID:  5484


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.

Job Description

The Director, Site Quality System provides leadership at the Center Valley, Breinigsville, and Westborough locations ensuring that the QMS to ensure compliance is maintained with regulatory requirements along with the business strategy of the company. Serves as the Quality Leader providing training and mentoring to the organization in quality matters supporting, procurement, manufacturing, returns and servicing of products managed at the locations. Is the Management Representative for both the locations.

Job Duties

* Serves as the Management Representative for Westborough, Breinigsville and Center Valley locations.


* Manages facility audits by outside agencies and internal Olympus compliance group to demonstrate compliance to regulatory requirements and Quality System.


* Ensures audits conducted that result in deficiencies are corrected per policy.


* Manages the development and performance of staff. Ability to assess and develop team talent to support business objects and personal objects of employees.


* Prioritize resources based on the strategic objectives of the organization.


* Establishes the departments objectives (MBO) to meet Quality Objectives organizations goals and strategic plan.


* Provides leadership in establishing processes or systems to support the Quality Systems vision for the locations .


* Drives the development and deployment of innovative global policies requirements and strategies for Quality Systems.


* Change agent to break down barriers to prepare and influence direct team other functions at locations to new ideas and ways to execute Quality Systems sub-systems to improve Olympus compliance profile.


* Leads quality sub-system process improvement projects to increase efficiency of the QMS at the locations.


* Leads QMS governance through execution of Management Review, CAPA, Non-Conformance, and audit sub-system ownership for locations.


* Accountable for QMS KPI execution results. Monitor key performance indicators and prepare progress reports for Quality Review meetings and for senior management.


* Develops QMS competency for all employees at the locations.


* Champion the development, implementation and continuous improvement of a Quality Management System to meet applicable standards and regulations and/or harmonize with global Olympus Quality Systems. Develop and revise Policies, SOP and WI as needed.


* Manage activities related to product acceptance and Ship Hold Communicates issues or developments identified during quality assurance activities and provides recommended improvements. Develop and execute strategies for addressing quality issues.


* Perform special assignments as directed

Job Requirements



* Bachelor’s degree in engineering, technical discipline, or equivalent.


* Minimum of 7 years of experience supporting or working within a medical device, or any other regulatory controlled industry.


* Minimum of 7 years of experience of improvement and/or maintaining quality management system within Medical Device or regulated industry.


* Minimum of 5 years’ experience in a leadership role managing people ideally across multiple locations.


* Experience with U.S. FDA QSR requirements, ISO13485, ISO14971, Japanese Pharmaceutical Affairs Law (JPAL), and Canadian Medical Device requirements. 


* Travel: Domestic 25%, between Westborough, MA and Center Valley, PA.


* Flexible working hours across multiple time zones for product related issue.




* Highly motivated strategic thinker with strong leadership, organizational, proven problem-solving and decision-making capabilities.


* Proven success in driving and managing cultural change


* Ability to understand business needs/requirements and system capabilities to develop efficient and effective solutions.


* Proficient with DMAIC / Black Belt / Six Sigma type tools to analyze, drive root cause, and solve problems.


* Highly proficient in Microsoft Word, PowerPoint, Excel, Visio, Project

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


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


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.


Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || 

Job Segment: QA, Quality Assurance, Six Sigma Black Belt, Business Process, Quality, Technology, Management

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