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Principal Quality Engineer (Remote)

Company

Olympus Corporation of the Americas
Address , Center Valley, 18034
Employment type
Salary
Expires 2023-09-17
Posted at 8 months ago
Job Description

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.

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

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

Job Qualifications

Required:

  • 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.
  • Will work with global teams, availability will include working across the associated time zones. International and domestic travel up to 15% of the time.
  • Minimum of 8 years related experience, preferably in the medical device industry related to process/quality engineering.
  • Bachelor’s degree in Engineering discipline or equivalent. Master’s Degree preferred.


Preferred:

  • Leadership experience: proven ability to lead and manage cross-functional teams, effectively communicate with all levels of management, and drive effective change.
  • Viewed as an expert in the quality field.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization and/or guidance exists.
  • Strong Quality Science skills including demonstrated statistics application and problem solving
  • Excellent verbal and written communication skills demonstrated by ability to generate technical reports, and ability to make presentations to middle and upper management
  • Skills: 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.
  • Proven Project Management skills, with ability to produce results.


#LI-Remote

Why join Olympus?

Here, people matter—our health, our happiness, and our lives.

  • Diversity & Inclusion Programs including Colleague Affinity Networks
  • Educational Assistance
  • Comprehensive Medical, Dental, Visions coverage effective on start date
  • 24/7 Employee Assistance Program
  • Parental Leave and Adoption Assistance
  • Volunteering and charitable donation match programs
  • Free virtual live and on-demand wellness classes
  • Work-life balance supportive culture with hybrid and remote roles
  • Competitive salaries, annual bonus and 401(k)* with company match
  • On-Site Child Daycare, Café, Fitness Center**
  • 12 Paid Holidays
  • 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.

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.

Olympus requires all US new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.


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 ||