Quality Engineering Senior

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. ​Patient Focus, Integrity, Innovation, Impact and Empathy. Job DescriptionThe Product Quality Engineer is responsible for the design, development and management of projects for legacy products. The Product Quality Engineer provides organizational support with a focus on Design Quality activities. Works with internal/external manufacturers providing finished products, services, components, and sub­assemblies to ensure compliance with company policies and procedures and medical device regulations. The Product Quality Engineer will partner with Operations, R&D, Supply Chain and other departments to continuously improve products and processes that meet all internal and external requirements and regulations. Job DutiesDrive the design & execution of Production Release Process project for components & finished devices.Lead and implement complex projects including quality improvement initiatives.Lead Process/Design Risk Analysis.Provide leadership in understanding of the quality regulations to other disciplines.Support Process/Design ValidationNerification activities and approach including software validation.Lead implementing limited cost of quality concepts, including cost of quality, data collection, & reporting.Support Manufacturing Engineering in the creation of DMR, DHR, routes, and bills of material, print changes, and specifications for in-house / external manufacturing. Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times. Job QualificationsRequired:Bachelor's Degree in Engineering required.Minimum of 5 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment.Proven track record in Sustaining Engineering, support of commercialized products and Post Market Surveillance. Strong working knowledge of statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab. Strong working knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, ISO 14971, ISO 11135, EUMDR and Human Factors. Well organized, flexible self-starter, team motivated and excellent at prioritizing and multi-tasking. Up to 10% domestic travel.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 matchComprehensive medical, dental, vision coverage effective on start date24/7 Employee Assistance ProgramFree live and on-demand Wellbeing ProgramsGenerous Paid Vacation and Sick TimePaid Parental Leave and Adoption Assistance*12 Paid HolidaysOn-Site Child Daycare, Café, Fitness Center**Connected Culture you can embrace:Work-life integrated culture that supports an employee centric mindsetOffers onsite, hybrid and field work environmentsPaid volunteering and charitable donation/match programsEmployee Resource GroupsDedicated Training Resources and Learning & Development Programs Paid Educational Assistance*US Only**Center Valley, PA and Westborough, MAAre you ready to be a part of our team?The anticipated base pay range for this full-time position in this location is $95,904.00 - $129,470.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). 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. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. 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 your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus View phone number on click.appcast.io).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) || Minnesota (US-MN) || Brooklyn Park || Quality & Regulatory Affairs (QA/RA)