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Quality System Engineer, Principal

Olympus Medical Systems

Olympus Medical Systems

Quality Assurance
Westborough, MA, USA
Posted on Sunday, April 28, 2024

Working Location: MASSACHUSETTS, WESTBOROUGH; CALIFORNIA, SAN JOSE; NATIONWIDE; PENNSYLVANIA, CENTER VALLEY; TENNESSEE, BARTLETT

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

To develop, maintain and continuously improve the Quality System across the Americas by driving industry best practices, procedural harmonization and seamless quality system integration.


Act as an ambassador of global quality harmonization to share, develop, deploy and integrate strategic plans and practices across Olympus globally. To interface with functional business partners within the quality system to ensure that development and implementation of the quality system meets business needs as well as enables innovation and flexibility in the business.

Job Duties

  • Ensure that a Quality System is established, implemented, and maintained to the highest levels of accordance with US and Internation requirements.
  • Review and approve release of changes to QMS documentation and assess impact to QMS certification, addressing any substantial changes with the Notified Body.
  • Ensure Intercompany Quality Agreements are established and maintained.
  • Manage Notified Body communication and relationship.
  • Support and participate in internal and external Quality Audits (including health authorities and notified bodies) an ensure related corrective action activities are completed in a robust and timely manner.
  • Support the CAPA process.
  • Show strong ability to influence without direct authority across functional groups, regions and leadership.
  • Provides resident expertise in the application of Quality sciences including data analysis, problem solving and the creation of system solution for Quality System issues.
  • Will act as an expert resource in applicable standards and local QMS requirement knowledge for cross functional teams.
  • Lead/support significant Quality System projects effectively using a working knowledge of project management techniques.
  • Develop innovative and practical solution to complex and unique process problems and system improvement through the use of best practices
  • All Other Essential Duties as directed.

Job Qualifications

Required:

  • BS degree or equivalent in an engineering or life science discipline. Master’s Degree preferred.
  • Minimum of 8 years’ experience working in a highly regulated industry required.
  • Demonstrated ability to manage and complete multiple projects and objectives and lead projects with cross-functional teams.
  • Proficient with Risk Management practices and Regulatory Requirements such as FDA, QSRs, ISO 13485.
  • Experience in audit management, front room and back-room coordination and best practices.
  • Will work with global teams, availability will include working across the associated time zones.

Preferred:

  • Minimum of 3 years’ experience working in an FDA regulated environment preferred.
  • Six Sigma Black Belt preferred.
  • Knowledge of emerging regulatory standards and changes to global regulatory landscape preferred.
  • Must be self-motivated with a strong sense of urgency to solve issues and the ability to consistently deliver on required activities.
  • Strong track record of leading and influencing without direct authority.
  • Excellent interpersonal, communication (written and oral), presentation and facilitation skills.
  • Proficient in most common PC based applications (work, excel, PowerPoint, Project, & Visio).
  • Demonstrate the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company

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 $116,751.00 - $163,452.00 / 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)