Senior Engineer, Quality System

Req ID: 10814

Working Location: Pennsylvania, Center Valley

Workplace Flexibility: Hybrid

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

To develop, maintain and continuously improve the Quality System across the Americas by driving industry best practices, procedural harmonization and seamless quality system integration. 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 and 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.
Ensures that the quality procedures are standardized throughout the business and ensures that they are implemented consistently and correctly.
Identifies areas of focus through data driven trending and brings solutions to management.
Lead CAPAs as process coordinator – execute on CAPAs when assigned as CAPA owner.
Support and participate 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.
Will act as an expert resource in applicable standards and local QMS requirement knowledge for cross functional teams.
Compile and support Quality System Management Reviews with site leadership.
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.
Leads/supports 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.
All Other Essential Duties as assigned by Management.

Job Qualifications

Required:

Minimum of 5 years’ experience in a highly regulated manufacturing environment required.
Ability to identify issues determine root cause and implement solutions.
Ensure compliance to standards regulations and Company procedures.
Identify and facilitate process and SOP improvements within the Quality System embracing a culture of continuous improvement.
High level of proficiency in most common PC based applications (Microsoft Word, Outlook, Excel and PowerPoint required - Visio skills desirable).
Demonstrated ability to manage and complete multiple projects and objectives.
Works precisely according to procedures rules and regulations has a passion for continuous improvement and quality.
Must be self-motivated with a strong sense of urgency to solve issues and the ability to consistently deliver on required activities.
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 2 years’ experience working in an FDA regulated environment preferred.
Knowledge of regulatory requirements such as FDA QSRs, ISO 13485, & EU MDR 2017/745 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 benefits 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.

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) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)

Job Segment: Senior Quality Engineer, Quality Engineer, Systems Engineer, Manufacturing Engineer, QA, Engineering, Quality

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