Working Location: Pennsylvania, Center Valley Workplace Flexibility: Remote 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: <a href="https://www.olympusamerica.com/careers">https://www.olympusamerica.com/careers</a>.<div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Job Description</H2> </div><div><div> <div> This role represents the Voice of Quality (design quality, reliability, ops/mfg. quality, supplier quality, quality systems, post market quality, etc.) on cross-functional new product development (NPD) project core teams. This role is responsible and empowered to establish the quality and reliability strategy and DRM metrics for the project. This position has responsibility for influencing product quality and reliability outcomes across NPD and serves as the final quality authority on the project team. </div> </div> <div> </div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Job Duties</H2> </div><div>This position provides oversight for multiple project areas including, but not limited to the following: <ul style="list-style-type:disc"> <li>Functional expertise to NPD projects and represent voice of quality on cross functional project teams</li> <li>Project management for the extended Quality team of one or more NPD projects</li> <li>Project management of initiatives to improve the quality and consistency of quality business processes and work product</li> <li>Applies the requirements of the Quality System to processes, products or services</li> <li>Supports validation and verification strategy for new and existing products and processes as assigned</li> <li>Develops and drives measurable Quality Improvements relating to products processes and services</li> <li>Develops Quality functional strategies, plans and schedules to meet project goals and manage risks</li> <li>Manages Quality escalations and drive resolutions with Core Team by working cross-functionally to ensure issue ownership, action and appropriate communication</li> <li>Drives critical thinking, functional excellence, lessons-learned and business and quality management system improvement</li> <li>Represents Voice of Quality for assigned project(s)</li> <li>Ensures design and quality requirements are effectively defined and implemented</li> <li>Proactively drives and champions strategic quality, reliability and safety initiatives such as DFSS activities, DFR, DFM, complaint reduction, risk management, etc.</li> <li>Identifis quality risks and implements risk burn down strategies</li> <li>Drives/leads root cause analysis and closed-loop corrective/preventive action</li> <li>Ensures an effective transfer to global post-market quality functions</li> <li>Coaches & supports project team members on compliance with quality system requirements</li> <li>Provides quality functional support for key project activities and deliverables including design history file (DHF), device master record (DMR), regulatory submissions, issue resolution, etc.</li> </ul></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Job Qualifications</H2> </div><div>Required: <ul style="list-style-type:disc"> <li>Bachelor of Science, medical, engineering, or scientific discipline required. Design or Process Green I Black Belt is a plus </li> <li>Minimum of 8 years of experience within a drug/device manufacturer/distributor with a focus on QSR compliance and quality assurance. </li> <li>Minimum of 5 years’ experience supporting new product development with 3+ years of experience as a Quality Core Team member.</li> <li>Knowledge of basic mechanical, electric, software, optical, or biological engineering.</li> <li>Knowledge of basic medical device regulations and standards (e.g. 21CFR part 820, ISO 13485, ISO 14971).</li> <li>Working knowledge of problem-Solving Tools (i.e. Process Mapping Histograms FMEA Risk Assessment Cause & Effect Diagrams PDCA Pareto Analysis etc.).</li> <li>Working knowledge of Quality Tools (i.e. Quality Planning Quality Costs and Assessment Basic Statistics Advance Statistical Techniques Technical Writing Metrology & Calibration Inspection and Testing Sampling Principles and Six Sigma etc.).</li> <li>Knowledgeable about extended Quality team functions throughout the product development process.</li> <li>Collaborative across functional boundaries in matrixed organizational structure.</li> <li>Proven track record in New Product Development delivering on robust, customer and patient focused product quality.</li> <li>Strong technical skills related to product quality including VOE translation to Design Inputs and Outputs, Design Characterization, Verification / Validation, Test Method Validation, and Statistical techniques.</li> <li>Strong working knowledge of FDA QSR's, MDSAP, ISO 13485, Design Controls, and Risk Management practice.</li> <li>Good 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.</li> <li>Proficient in the use of Information Technology and applications.</li> <li>English ability: TOEIC 600 plus or equivalent.</li> <li>Strong collaboration skills and the ability to work across functions and geographies.</li> <li>Up to 10% domestic/international travel.</li> </ul></div></div></div>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: <ul> <li> Competitive salaries, annual bonus and 401(k)* with company match </li> <li> Comprehensive medical, dental, vision coverage effective on start date </li> <li> 24/7 Employee Assistance Program </li> <li> Free live and on-demand Wellbeing Programs </li> <li> Generous Paid Vacation and Sick Time </li> <li> Paid Parental Leave and Adoption Assistance* </li> <li> 12 Paid Holidays </li> <li> On-Site Child Daycare, Café, Fitness Center** </li> </ul> Connected Culture you can embrace: <ul> <li> Work-life integrated culture that supports an employee centric mindset </li> <li> Offers onsite, hybrid and field work environments </li> <li> Paid volunteering and charitable donation/match programs </li> <li> Employee Resource Groups </li> <li> Dedicated Training Resources and Learning & Development Programs </li> <li> Paid Educational Assistance </li> </ul> *US Only **Center Valley, PA and Westborough, MA Are you ready to be a part of our team? Learn more about our benefits and incentives: <a href="https://www.olympusamerica.com/careers/benefits-perks">https://www.olympusamerica.com/careers/benefits-perks</a>. 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 <a style="color:#0563c1;text-decoration:underline" href="https://www.olympusamerica.com/">www.olympusamerica.com</a>. You Belong at Olympus We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply. Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [email protected]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787). 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. <div> </div> Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/RA)

Senior Manager, Quality Core Team (2 of 2) (Japan Based) (Center Valley, PA, US, 18034-0610) @ Olympus Corporation of the Americas

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