Principal Engineer, Quality Systems

Req ID: 9788

Working Location: MASSACHUSETTS, WESTBOROUGH

Workplace Flexibility: Field

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.

Job Description

To develop, maintain and continuously improve the Quality System across the Americas by specifically supporting the Westborough site in by driving industry best practices, procedural harmonization and seamless quality system integration through development of robust Quality plans. 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

Ensures that a Quality System is established, implemented, and maintained to the highest levels of accordance with US and International requirements.
Review and approve release of changes to QMS documentation.
Coordinate with other functions and sites to ensure accurate, complete, and efficient change processing.
Ensure implementation and execution of global corporate procedures into regional practices.
Identify areas of focus through data-driven trending and bring solutions to management.
Ability to synthesize quality signals, extract critical information to inform plans, and develop actions for addressing and improving the quality system.
Support internal and external Quality Audits (including notified bodies and health authorities) and ensure related corrective action activities are completed in a robust and timely manner.
Act as Audit Finding coordinator.
Support CAPA process, monitor progress of records, help facilitate CAPA board meetings, and support CAPA owners to drive closure of corrective action plans.
Show strong ability to influence without direct authority across functional groups, regions, and leadership.
Provide resident expertise in the application of Quality Sciences including statistics, data analysis, problem-solving, and the creation of system solutions for Quality System issues.
Act as an expert resource in applicable standards and local QMS requirement knowledge for cross-functional teams.
Report on the performance of the quality system to Company management, as directed, for review and as a basis for improvement of the quality systems.
Lead/support significant Quality System projects effectively using a working knowledge of project management techniques.
Develop innovative and practical solutions to complex and unique process problems and system improvement through the use of best practices.
Perform 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 6 years’ experience working in a highly regulated industry required.
Demonstrated ability to manage and complete multiple projects and objectives and lead cross-functional teams.
Proficient with DMAIC / Lean Six Sigma /Black Belt type tools to analyze, drive root cause, and solve problems.
Proficient with statistics, sampling strategies, quality systems trending, process capability.
Proficient with Risk Management practices, Corrective and Preventative Actions, Process Validation and regulatory requirements such as FDA QSRs, ISO 13485, ISO 14971.
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 across functional groups, leadership levels and regions globally.
Excellent interpersonal, communication (written and oral), presentation and facilitation skills.
Demonstrated ability to coach and mentor resources.
Proficient in most common PC based applications (Word, Excel, PowerPoint, Project, & Visio).
Demonstrates the highest ethical standards actively promotes trust respect and integrity in all dealings both inside and outside the Company.
All Other Essential Duties as assigned by Management.

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.
Experience in audit management, front room and back room coordination and best practices 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 benefit and incentives.

The anticipated base pay range for this full-time position working at this location is $119,670.00 - $167,538.00 / 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 value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development.

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)

Job Segment: Six Sigma Black Belt, Six Sigma, Lean Six Sigma, Systems Engineer, Quality Engineer, Management, Engineering

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