Principal, Global QMS Training

Industry: RA/QA

Company: Olympus Corporation of the Americas

Working Location: NATIONWIDE; BRAZIL, SAO PAOLO; Canada; Mexico, All Mexico; PUERTO RICO, SAN JUAN; Puerto Rico

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.

**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, Global QMS Training will serve as an individual contributor within Global QMS Training.

This individual will support the management of the global training process, lead strategic training projects; including compliance and process improvements, and drive process alignment and compliance by end users, collaborate with global process owners and cross-functional teams to develop and implement key learning strategies and programs in support of Global QMS strategies and goals.

Job Duties

• Support the management of the global training process, including global documentation, strategy, compliance, administration on the LMS, and audit needs.
• Lead activities to support end users with use and implementation of the global training process and systems.
• Consult with process owners on the end-to-end strategy based on business requirements and opportunities for improvement (needs assessment, design, development, implementation, and effectiveness) for training or other solutions for global QMS training programs across Olympus.
• Lead initiatives for the development and use of reports in support of audits, manager accountability, and business partner requirements.
• Work with vendors to provide quality cost-effective solutions as needed.
• Organize and implement the delivery of learning solutions including the sustained forecasting and delivery of programs to meet business needs.
• Partner with the learning administration team to manage assignments, including data analysis.
• Participate in project teams, as a training process SME, to improve overall compliance performance to established metrics and requirements.
• Provide support on quality and compliance projects as requested, and perform other assigned duties, as needed.
• Partners with teams on the communication and change management activities for training implementations.

Job Qualifications

Required:

• A minimum of a 4-year college degree (Bachelor’s Degree) or equivalent is required
• A minimum of 8 years of professional experience in the medical device or pharmaceutical industry is required.
• A minimum of 8 years of developing and implementing training program experience in a medical device or pharmaceutical environment, preferably to global users.
• A minimum of 5 years’ experience with utilizing a Learning Management System.
• Working knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, SOR 98-282 CMDR (Canada), J-PAL (Japanese), European Medical Devices Directives, European Medical Devices Regulations, ANVISA 16/2013 (Brazil), TG(MD)R Sch3 (Australia), and any other regulations or standards applicable to the site is required.
• Strong project management skills; strong computer skills and use of software applications such as MS Windows, MS Office (Word, Excel, PowerPoint); strong written and oral communication skills, are required
• Approximately 10% travel, including globally.
• Availability to take evening and early morning teleconferences.

Preferred:

• Experience supporting the learning and development need of an Operations environment preferred.
• Knowledge and understanding of regulatory and technical training requirements and associated processes.
• Project management experience strongly preferred particularly in the design implementation and sustainment of learning and performance initiatives/processes.
• Experience presenting information in a front room audit situation.
• Experience with public speaking and facilitation skills.
• Thorough knowledge of adult learning training and applying development principles and techniques for success.
• Knowledge of the application of Learning Management Systems or tools.
• Knowledge and experience with current and emerging Learning Technologies preferred.
• Global communication capabilities
• Experience in working within or with Japanese companies is desirable.

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.

The anticipated base pay range for this full-time position working at this location is $90,243.00 – $126,339.00 / 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.

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)