Global Principal Quality Engineer, QMS Transformation - Remote

Working Location: MASSACHUSETTS, SOUTHBOROUGH; PENNSYLVANIA, CENTER VALLEY 

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 Global Principal Quality Engineer (QMS transformation) is responsible for the creation and delivery of a comprehensive Global  CAPA training program across the Olympus network, building competencies, CAPA training  tools , designing  training programs, e- learnings and coaching CAPA hours coaching  channels throughout the Americas, EMEA, Japan, China, and APAC region to deliver strong understanding and applicability of Quality Management, CAPA and Non-conformance process steps, Analysis of complex data, risk assessment tools,  basic problem solving, root cause analysis, Human Error Analysis for prevention to ensure patient safety and company compliance

Job Duties

• Creating engaging learning activities and compelling QMS course content through seeking inputs from SME and identifying target audience needs.
• Applying tested instructional design theories, practice, and methods to deliver effective training programs. 
• Create supporting material / media (audio, Computer based training modules, storyboards, video, simulations, role plays, games, interactive quizzes etc).
• Performs research and designing situation-appropriate learning content for virtual or in class and measuring the results of training effectiveness and skill enhancement that is visualized in a Competency Model Score Card for global Engineers in Problem Solving, Green belt and Black belt development.
• Supports LMS relevant information for timely reports and pushing learning items in learning catalogue for global attendance.
• Manages online learning communities and LMS content to effectively convey technical information to non-technical, first-time user or advanced user in the CAPA community of practice on Problem Solving, Technical writing and CAPA tools.
• Support and participate in internal and external Quality Audits (including notified bodies and health authorities) and ensure related CAPA activities are completed in a compliant and timely manner.  
• Collaborates with Subject Matter Experts on the learning needs and strategies across Olympus sites.
• Ability to lead indirect resources to develop training team network across Olympus.
• Collaborates with Olympus business partners to align training needs and system tool usage to facilitate types of training and tracking.
• Maintains training records directly or indirectly through Olympus locations.
• Collaborates with global CAPA community to understand future training needs and delivers solutions to enhance CAPA competency excellence and driving value to the business.
• All Other Essential Duties as assigned by Management. 

Job Qualifications

Required:

• BA/BS medical, engineering, scientific discipline
• Black Belt / Green Belt, Continuous improvement techniques and/or demonstrated problem solving and root cause techniques.
• Minimum of 8 years’ professional experience in a medical device manufacturer with demonstrated results in transformational Leadership inclusive of effective CAPA process & QMS to International Regulations and standards. 
• Minimum of 5 years’ experience as Learning and Development Manager, Training Manager or similar, preferably to global users. Proven experience in the delivery of training with excellent presentation public speaking and facilitation skills.
• Demonstrated experience in collaboration driving strong governance of a process and driving targeted improvements in performance.
• Demonstrated experience leading global change initiatives and integrations for multi-site and multi-product businesses through collaboration with the business and effectively interact with and influence teams and managers.
• Demonstrated experience in developing and leading skill enhancement of teams on strong problem solving, technical writing and statistical techniques.
• Competent understanding of International medical device regulations specific expertise in; Regulatory Inspections, CAPA policy development & implementation, Mentoring and Coaching of teams, Strong analytics driving proactive solutions and demonstrated enhancements on CAPA principles.