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Director, Quality Systems

Olympus Medical Systems

Olympus Medical Systems

Quality Assurance
Westborough, MA, USA
Posted on Wednesday, June 26, 2024

Working Location: MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY

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.

**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 Director Quality Systems is responsible for implementing and maintaining quality metric data programs relating to global Olympus products, processes and sites. This role will determine requirements to provide standardized global quality data metrics.


This role will partner close with other Quality and cross-functional leaders at site and global levels to enable visibility to data related the Quality Management System and enable timely action to quality signals.

Job Duties

  • Develops and maintains Olympus global Quality Data Scorecard
  • Establishes a process to ensure timely reaction and response to quality signals such as complaints, CAPAs, non-conformance trends and others based on the Quality Data Scorecard.
  • Provides thought leadership and collaboration opportunities in the space of quality metrics/analytics throughout Olympus
  • Establishes effective QMS data governance processes and leads strategies for its effective use across Olympus Quality organization
  • Analyzes industry quality metrics, benchmarking, and trends to understand changes in the competitive or regulatory landscape to adjust plans as appropriate.
  • Maintains Quality Data Scorecard programs, policies, processes, procedures, and controls ensuring adherence to established standards and agency guidelines.
  • Drives and continuously improves Quality Data Scorecard Programs across the various levels of the organization (EMR, Site QMRs, Quality Core KPIs, etc.)
  • Advances the technology strategies in support of Data analytics and the effective implementation of predictive data science solutions to drive risk mitigation.
  • Conducts data analysis for key insights on decision making and provides consultation on leading indicators.
  • Manages and provides guidance to team members, including organizing and prioritizing group tasks, performing training, and managing performance.

Job Qualifications

Required:

  • BS or MS in engineering or science related degree
  • A minimum of 15 years of relevant Quality Management System experience in a medical device or pharma or other regulatory controlled industry (medical device preferred).
  • Comprehensive understanding of global regulatory standards, including ISO 13485:2016, ISO 9001:2015, and FDA Quality System Regulation.
  • Since this is a Global role, the individual will be expected to schedule meetings that work for multiple time zones and 10% travel should be expected.

Preferred:

  • Demonstrated experience in developing and leading a quality team.
  • Exceptional communication skills, both verbal and written, with the ability to engage with stakeholders at all levels.
  • Ability to thrive in a fast-paced environment, demonstrating efficiency and proactivity. Strong problem-solving abilities and strategic thinking.

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 $128,490.00 - $179,886.00 / 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)