Location: Southborough, MA
Company: Olympus
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 backssment 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. Competent understanding of International medical device regulations specific expertise in ISO 13485, 21 CFR Part 820, ISO 14971, SOR 98-282 CMDR (Canada), J-PAL (Japanese), European Medical Devices Directive.
Up to 25% international travel Availability to take evening and early morning teleconferences and training Proficiency in English and additional Languages preferred e. g. Japanese / German Preferred: 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. Demonstrated leadership in managing Regulatory Inspections & Notified Body audits. Excellent communication, project management, and budgeting skills.
Strong capability to influence at multiple levels within the organization on CAPA policy development & implementation, Mentoring and Coaching of teams. Strong interpersonal, analytical and project management in driving change. Competent with Microsoft Office 365 Suite, Visio, Adobe, Docu Sign, Agile and Windows platforms. 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 /careers/benefits-perks.
The anticipated base pay range for this full-time position working at this location is $100,022.00 - $140,032.00 / 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 . 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, interaction (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, interactionual 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) Southborough Quality & Regulatory Affairs (QA/RA)
Quality Assurance (QA) Jobs encompass roles focused on ensuring that products or services meet established standards of quality, reliability, and performance. These positions typically involve identifying defects, designing test procedures, conducting tests, and making improvements. Key characteristics of QA jobs include attention to detail, a strong understanding of quality metrics, the ability to analyze data, and problem-solving skills. Individuals in QA roles work closely with development teams and are critical in maintaining customer satisfaction by preventing errors and enhancing the user experience.
Quality Assurance (QA) jobs involve ensuring that products or services meet certain standards of quality before they reach the consumer. Individuals in QA roles are responsible for planning and implementing inspection processes, conducting tests, and analyzing the results to detect defects. They work to prevent errors and improve the overall quality of the final output. Key characteristics of QA jobs include attention to detail, a systematic approach to problem-solving, and a strong understanding of industry-specific regulations and quality standards. These professionals play a critical role in customer satisfaction and maintaining the reputation of a brand or company.
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
Quality Assurance (QA) jobs entail roles focused on ensuring that products or services meet established standards and customer expectations. People in QA positions are responsible for designing testing processes, creating test plans, identifying defects, and preventing defects by examining the production process. They aim to enhance product reliability and actively work to maintain quality consistency. QA roles often require keen attention to detail, strong problem-solving skills, and an understanding of both product specifications and customer needs. QA is an integral part of product development and maintenance, bridging the gap between the manufacturing processes and the end users to ensure a satisfactory experience.
