Principal Engineer - Quality Systems Development & Standardization - Remote
Olympus Medical Systems
Working Location: MASSACHUSETTS, WESTBOROUGH
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.
To develop maintain and improve the Quality System across OGA such that it is concordant with domestic and international standards. To interface with users of the system to ensure that development and implementation of the Q S meets business needs. To assist all departments within the Organization and provide training in order to ensure that OGA Quality System Standards are met by performing the outlined responsibilities.
- Ensures that a Quality System is established and implemented in accordance with US and International requirements and must report on the performance of the quality system to the Company's management as directed for review and as a basis for improvement of the quality system. This responsibility includes liaison with external parties on matters relating to the organization's Quality System and its continued development in accordance with changes in Regulatory Agency requirements and Business needs.
- Ensures through systems that the quality procedures are standardized throughout the business and ensures that they are implemented consistently and correctly.
- Provides resident expertise in the application of Quality Sciences including statistics data analysis problem solving and the creation of system solutions for Quality System issues.
- Supports the development implementation and maintenance of Training Learning & Development Tools throughout the business.
- Ensures that managers of personnel within the organization can implement and maintain training needs to meet their respective responsibilities by supporting the development and implementation of systems.
- All Other Essential Duties as directed.
- Bachelors degree or equivalent and a minimum of 8 years related experience and or training; or the equivalent combination of education and experience.
- Requires background and familiarity with U.S. FDA QSR requirements including ISO 9001 MDD 93 42 ISO 13485 2003 and Canadian Medical Device requirements and the ability to educate and advise others on related subject matter.
- Strong Quality Science skills including statistics application and problem solving.
- Ability to interpret external and internal requirements and correlate those requirements with the QS.
- Ability to create and deliver training to all levels within the organization.
- Strong people skills ability to effectively interact at all levels within the corporation.
- Ability to drive and influence change. Strong capabilities in driving team activities and consensus building.
- Ability to read analyze and interpret general business periodicals professional journals technical procedures or governmental regulations.
- Ability to write reports business correspondence and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers clients customers and the general public.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written oral diagram or schedule form.
- Engineering degree preferred.
- Experience in medical device product development and manufacturing with strong quality background preferred.
- Excellent verbal and written communication skills.
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**
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 $115,026.00 - $161,036.00 / 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.
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.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)