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Senior Manager Global QMS Training - Remote

Olympus Medical Systems

Olympus Medical Systems

Westborough, MA, USA
Posted on Thursday, January 25, 2024

Working Location: MASSACHUSETTS, WESTBOROUGH

Workplace Flexibility: Hybrid

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

The Senior Manager, Global QMS Training will serve as a manager within QARA having responsibility to lead learning and development dedicated for all personnel who work within the global quality management system (QMS). Responsibilities include the development, delivery, implementation, evaluation, and administration of global QMS training that builds the Olympus capability in alignment with the business goals and skills.

Job Duties

  • Manage the global training process, including global documentation, strategy, compliance, administration of the LMS, and audit needs.
  • Lead the end-to-end strategy (needs assessment, design, development, implementation, and effectiveness) for training or other solutions for global QMS training programs across Olympus.
  • Manage and supervise employees developing, monitoring, and implementing Global QMS training requirements and managing the global learning management system.
  • Lead, manage, and support the development and use of reports in support of audits, manager accountability, and business partner requirements.
  • Leads as needed and/or supports negotiations and project management of resources, schedules, contracts and fees for externally developed programs or training updates. Work with vendors to provide quality cost-effective solutions as needed.
  • Collaborate with Subject Matter Experts on the current learning needs and strategies, as well as anticipating future training needs based on business requirements and opportunities for improvement.
  • Organize and implement the delivery of learning solutions including the sustained forecasting and delivery of programs to meet business needs and any re-training actions necessary.
  • Create and manage assignments, including data analysis.
  • Serve on cross-site project teams consistent with company objectives to improve overall compliance performance to established metrics and requirements
  • Research emerging regulatory trends and changes in regulations and standards to incorporate into training programs.
  • Monitor and evaluate training program’s effectiveness and periodically reports to senior management progress or issues.
  • Utilize cost-effective, consistent and best-practice training methods and ensures compliance with both regulatory and internal compliance.
  • Lead or support special quality and compliance projects as requested, and perform other assigned duties, as needed.
  • Leads and supports communication and change management activities for training implementations.
  • Collaborate with department management in the preparation of annual training plans and budgets.

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.
  • Knowledge and experience developing and implementing training programs using current and emerging training authoring tools preferred (e.g., Articulate 360, Brainshark)
  • 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
  • Knowledge and understanding of regulatory and technical training requirements and associated processes.
  • Proven experience in the delivery of training with excellent presentation 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.
  • Approximately 20% 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 experience with current and emerging Learning Technologies preferred.
  • Project management experience strongly preferred particularly in the design implementation and sustainment of learning and performance initiatives/processes.
  • Experience in working within or with Japanese companies is desirable.

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 $129,404.00 - $181,166.00 / 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.

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)