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Global Principal Quality Engineer (Process Validation) - Remote - Center Valley, PA, US, 18034-0610

Working Location: PENNSYLVANIA, CENTER VALLEY; Nationwide 

Workplace Flexibility: Field

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

Develop, maintain, and support the company Quality System, regulatory requirements and business strategy. Continuously improve Quality performance related to New Product Development, procurement, manufacturing, and metrics related to the strength of the site Quality System. Leads complex projects. Mentors less experienced engineers within and across Olympus sites in best practices for the use of Quality tools and methods.

Job Duties

  • Leads and participates in Cross-Functional Teams to support new product development, procurement, manufacturing representing Quality Engineering discipline
  • Direct experience with manufacturing of Medical Devices
  • Completes assigned Quality Engineering tasks to schedule.
  • Leads promotion of Quality and Regulatory requirements.
  • Leads or participates in the development of process and procedure development/changes
  • Provides resident expertise in the application of Quality Sciences including statistics, data analysis, problem solving, and the creation of system solutions.
  • Develops new approaches to solve problems identified as part of the team.
  • Assists others to lead and develop novel approaches within the5E teams.
  • Serves as a mentor and advisor for the Quality team to assist in developing Quality Engineering skills and capabilities.
  • Applies the requirements of the Quality System to processes, products or services 
  • Leads, supports, and guides the manufacturing (as needed) to address quality issues and resolution using the best Quality techniques and principles.
  • Develops and maintains the validation and verification strategy for new and existing products and processes
  • Leads the development and maintenance of Master Validation Plans
  • Monitors product and process performance metrics and acts upon trends with minimal guidance.
  • Authors, collaborates, and approves Quality System documentation including change orders, DHF, DMR, DHR, labels and labelling, etc.
  • Develops and drives measurable Quality improvements relating to products, processes and services.
  • Applies defined product requirements to manufacturing processes, test methods, and services
  • All other essential related duties as required

Job Qualifications

Required:

  • Bachelor’s degree in Engineering discipline or equivalent - Master’s Degree preferred. 
  • Minimum of 8 years related experience, preferably in the medical device industry related to process/quality engineering.
  • Viewed as an expert in the quality field.
  • Leadership experience: proven ability to lead and manage cross-functional teams, effectively communicate with all levels of management, and drive effective change.
  • Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, ISO 13485, 14971 and the ability to educate others on related subject matter.
  • Strong Quality Science skills including demonstrated statistics application and problem solving 
  • Will work with global teams, availability will include working across the associated time zones.  International and domestic travel up to 15% of the time.

 

Preferred:

  • Excellent verbal and written communication skills demonstrated by ability to generate technical reports, and ability to make presentations to middle and upper management 
  • Proven Project Management skills, with ability to produce results. 
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization and/or guidance exists.
  • Problem Solving, Technical Aptitude, Attention to Detail, Solution Oriented, Effective Verbal and Written Communicator, Quality Engineering Disciplines, Quality Control Disciplines, Quality Systems Disciplines and Strategic Leadership.

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 $110,025.00 - $154,034.00 / 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) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA) 

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Job Profile

Regions

North America

Countries

United States

Skills

Communication Documentation Medical Devices Manufacturing Project Management Quality Engineering Quality Tools and Methods Regulatory Compliance Statistics

Tasks
  • Approve Quality System documentation
  • Complete Quality Engineering tasks
  • Develop and maintain validation and verification strategy
  • Develop, maintain, and support Quality System
  • Drive measurable Quality improvements
  • Lead complex projects
  • Lead promotion of Quality and Regulatory requirements
  • Mentor less experienced engineers
  • Monitor product and process performance metrics
  • Support new product development and procurement
Experience

8 years

Education

Bachelor's degree in engineering Master's degree

Restrictions

International and domestic travel up to 15% of the time

Timezones

America/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9