Director, Quality Systems

Req ID: 10072

Working Location: MASSACHUSETTS, WESTBOROUGH

Workplace Flexibility: Onsite

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.

Learn more about Life at Olympus: https://www.olympusamerica.com/careers.

Job Description

Oversee all aspects of the Quality Management System (QMS) across the Americas. Ensures the QMS design maintenance execution and governance supports business objectives through: proactive monitoring and application of global regulatory requirements within the regional QMS; leading the governance of the QMS in the Americas; development of employee QMS awareness knowledge and application; lead quality sub-system process improvement projects to increase efficiency of the QMS through enhancing employee interaction experience or making improvements to how product quality is approached.

Job Duties

Leads and directs Quality System team members in the Americas.
Manages the development and performance of staff.
Ability to assess and develop teamtalent 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 orsystems to support the Quality Systems vision for the OCA region.
Drives the development and deployment of innovative global policies requirements andstrategies 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.

Job Qualifications

Required:

Bachelor of Science required.
Minimum of 10 years Regulated Quality Experience.
Minmum 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 makedecisions and commit to a clear course of action; comfortable making decisions based on partial information.
Organization Agility to adapt to a changingenvironment 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.

Why join Olympus?

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

Equitable Offerings you can count on:

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**

Connected Culture you can embrace:

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

*US Only

**Center Valley, PA and Westborough, MA

Are you ready to be a part of our team?

Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.

The anticipated base pay range for this full-time position working at this location is $151,458.00 - $212,041.00 / 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.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

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.

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact 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).

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) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)

Nearest Major Market: Worcester
Job Segment: Six Sigma Black Belt, Six Sigma, Quality Manager, Document Control, Management, Quality, Administrative

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