Olympus Corporation · 1 week ago
Director, Quality Systems
Greater Boston
Full-time
Hybrid
Director/Executive
$151K/yr - $212K/yr
10+ years expOlympus Corporation is a global medical technology company focused on advancing medical technologies and elevating the standard of patient care. The Director of Quality Systems will oversee all aspects of the Quality Management System across the Americas, ensuring compliance with global regulatory requirements and leading quality improvement initiatives.
ElectronicsIndustrialManufacturingMedical DeviceProduct Design
Responsibilities
Leads and directs Quality System team members in the Americas
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 OCA region
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 and OCA sites to new ideas and ways to execute Quality Systems sub-systems to improve Olympus compliance profile
Monitors plans and applies Global regulatory or Olympus requirements into the QMS regionally and at the local level within the Americas
Leads quality sub-system process improvement projects to increase efficiency of the QMS Influence regional and global QARA com QMS strategic direction and initiatives
Leads QMS governance through execution of Management Review and CAPA sub-system ownership for the region
Accountable for QMS KPI execution results Develops QMS competency for all employees
Supports QARA Pillars QMS requirements
Aligns Quality System resource to support QARA Pillars across the region
QMS Subject Matter Expert to support QARA Compliance team during external and internal audits
Performs other related duties as assigned by management
Qualification
Required
Bachelor of Science required
Minimum of 10 years Regulated Quality Experience
Minimum of 7 years experience managing people ideally across multiple locations sites countries
Minimum of 7 years combined experience working in Quality Systems Document Control and Training
Minimum of 7 years experience managing the business aspects of quality and regulatory projects
Good analytical toolkit
Ability to influence outside of direct control at Sr. And International CQE and/or Six Sigma
Leadership through inspiring the team to execute commitments on time and to expectations
Building and leading a team with integrity and unity
Change agent to break down barriers to prepare and influence direct team other functions and OCA sites to new ideas and ways to execute Quality Systems sub-systems to improve Olympus compliance profile
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
Able to quickly make decisions and commit to a clear course of action; comfortable making decisions based on partial information
Organization Agility to adapt to a changing environment and new ideas with speed
Able to identify and articulate the strategic vision and direction for department to support the business objectives
Thorough knowledge of 21 CFR 820 and ISO 13485 required
Working knowledge of international medical device quality system requirements required
Complete understanding and application of principles concepts and practices of production manufacturing and quality system procedures required
Demonstrated success in the design and deployment of innovative quality systems
Travel up to 20% of the time availability to take evening and early morning teleconferences
Preferred
MBA Preferred
Medical Device Experience preferred
Black Belt Certification preferred
Comprehensive understanding of principles and concepts of Process Excellence, Statistical Process Control, and Applied Statistics preferred
Benefits
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 Child Daycare, Café, 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
Company
Olympus Corporation
Olympus is passionate about creating customer-driven solutions for the medical industry.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Yasuo Takeuchi
Executive Chairman
Recent News
2025-05-27
2025-05-19
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