Director, Quality Systems

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Working

Location:

Massachusetts, Westborough
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.

Oversee all aspects of the Quality Management System (QMS) across the Americas. Ensure the QMS design, maintenance, execution and governance support business objectives through proactive monitoring and application of global regulatory requirements, leading governance of the QMS in the Americas, developing employee QMS awareness and knowledge, and leading subsystem process improvement projects to increase QMS efficiency.

• Lead and direct Quality System team members in the Americas.
• Manage development and performance of staff.
• Assess and develop team talent to support business objectives.
• Prioritize resources based on strategic objectives.
• Establish department objectives (MBO) to meet quality objectives.
• Provide leadership in establishing processes or systems to support the Quality Systems vision.
• Drive development and deployment of innovative global policies, requirements and strategies.
• Act as a change agent to influence direct teams and other functions to adopt new ideas.
• Monitor plans and apply global regulatory or Olympus requirements into the QMS regionally and locally.
• Lead quality sub‑system process improvement projects to increase QMS efficiency.
• Lead QMS governance through Management Review and CAPA sub‑system ownership.
• Accountable for QMS KPI execution results.
• Develop QMS competency for all employees.
• Support QARA Pillar QMS requirements.
• Align Quality System resources to support QARA Pillars across the region.
• Serve as QMS subject matter expert during external and internal audits.
• Perform other related duties as assigned by management.

• Minimum of 10 years regulated quality experience.
• Minimum of 7 years experience managing people across multiple locations, sites and countries.
• Minimum of 7 years combined experience in Quality Systems, Document Control and Training.
• Minimum of 7 years managing business aspects of quality and regulatory projects.
• Bachelor of Science degree.
• Good analytical toolkit.
• Leadership through inspiring the team to execute commitments on time.
• Change agent who breaks down barriers to influence teams.
• Ability to assess and develop team talent and prioritize resources.
• Experience with 21 CFR 820, ISO 13485, and international medical device quality system requirements.
• Travel up to 20% of the time, including evening and early morning teleconferences.
• Strong analytical, organizational, and decision‑making skills.

• MBA.
• Medical Device Experience.
• Black Belt Certification.
• Comprehensive understanding of Process Excellence, Statistical Process Control, and Applied Statistics.

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

• 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 childcare, cafe, fitness center**.

• 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.
• U.S. only.
• Locations:
  Center Valley, PA and Westborough, MA.

• Seniority Level: Director
• Employment Type:
  
  Full-time
• Job Function:
  Quality Assurance
• Industries:
  M…