96 applicants
Olympus Corporation of the Americas · 2 days ago
Global Principal Quality Engineer (Process Validation)
Center Valley, PA
Full-time
Remote
Senior Level
$112K/yr - $156K/yr
8+ years exp
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Responsibilities
Leads and participates in Cross-Functional Teams to support new product development, procurement, manufacturing representing Quality Engineering discipline
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
Qualification
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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.
Benefits
Competitive salaries
Annual bonus
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
Company
Olympus Corporation of the Americas
At Olympus, we put a lot of good back into the world, and what we do, really matters.
5,001-10,000 employees
H1B Sponsorship
Olympus Corporation of the Americas has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (4)
2022 (3)
2021 (3)
2020 (4)
Funding
Current Stage
Late StageLeadership Team
Abigail Hunter-Syed
Director
Lyne Charron-Keller
Executive Director, Global Marketing, Respiratory Business
Recent News
2023-10-25
Company data provided by crunchbase
