Job Information
Olympus Corporation of the Americas Principal Quality Engineer in Center Valley, Pennsylvania
Working Location: NATIONWIDE
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 (https://www.olympusamerica.com/careers) .
**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.
Job Description
The Principal Quality Engineer is responsible for driving complex projects to completion by effectively managing all aspects related to such initiatives within the Quality organization. Primary focus will be on facilitating cross-functional team process improvements, developing actions, and tracking, where needed, to meet defined objectives while satisfying regulatory requirements and business strategy. This position requires a global outlook and the ability to integrate many different aspects of the organization, such as functions, departments, software platforms, etc. to ensure the project satisfies various stakeholders and areas of the business.
Job Duties
Leads and participates in cross-functional solution initiatives, such as defining scope, establishing an appropriate cross-functional team, planning, driving issues to resolution, escalating and mitigating risks, tracking, and reporting.
Provides expertise in the application of Quality Sciences including statistics, data analysis, problem solving and the creation of system solutions.
Define actionable KPIs that influence the organization's directions, identifies gaps, current limitations, and challenges.
Gathers, collates, maintains, distributes, and presents Emerging Issues report to internal stakeholders by soliciting input from supporting functions (e.g. Ship Hold, Regulatory Affairs, Health Hazard Assessment, etc.).
Sends leadership urgent or escalated product issue notifications in a clear and concise manner.
Works together with the Quality organization to identify, access, and analyze data that have impact on the company’s compliance with overall quality systems.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Advise management on potential improvements or enhancement to quality systems and processes in the company.
Evaluate current state business processes and identify opportunities for increasing efficiency, reducing cost, etc. and quantify the problem through solution.
Perform other duties as assigned.
Job Qualifications
Required:
Bachelor’s degree in a science, engineering discipline, or equivalent required. Master degree desirable.
Minimum of 10 years in medical device industry leading projects with a focus on process improvement and data analytics.
Requires background and familiarity with applicable regulatory requirements, including but not limited to U.S.FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA.
Proven ability to lead and manage cross- functional teams effectively communicate with all levels of management and drive effective change.
Experience in supporting sites / organizations through US FDA, Notified Body, and other International Regulatory Agency Audits.
Experience writing, reviewing, and providing feedback on requests for additional information or audit responses.
Experience working in a global organization and collaborating with multiple regions (Americas, EMEA, APAC, China & Japan) / company locations.
Experience working with, presenting, and communicating with executive leadership.
Experience with implementing tracking and monitoring tools.
Fluent in English language
Since this is a Global Role, the individual will be expected to schedule meetings that accommodate multiple time zones. International travel up to 25% of the time should be expected.
Strong Interpersonal Skills, Ability to manage complexity, analytical, people management on a global basis, office 365
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
Diversity Equity & Inclusion Initiatives including 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 (https://www.olympusamerica.com/careers/benefits-perks) .
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 .
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) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)