Working Location: WASHINGTON, REDMOND

　　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 Quality Engineer I is an entry-level role that provides Quality Engineering support to ensure compliance with the Quality System and business strategy of Olympus at the Redmond, WA facility. They are a representative of the Quality Department specifically allocated to supporting manufacturing of the Class III Spiration Valve System product line. The Quality Engineer I has responsibilities for various aspects of manufacturing from receiving of raw materials through to finished product, and in complaint investigations related to product in the field. They support the Site Quality Manager with ensuring compliance to the Quality Management System.

　　This job is intended to provide the applicant with a mixed experience through supporting roles designed to give them increasing autonomy and the opportunity to take on more responsibility over time. They will support the Site Quality Manager and other Quality Engineers with maintaining core processes and meeting key performance metrics, while simultaneously implementing new procedures. This role will primarily focus on day-to-day investigations for manufacturing issues and complaints. The balance of their time will be allocated to other projects and operations of the site.

　　Job Duties

　　Support preparation of change orders to part specifications, drawings, and inspection plans.

　　Support the ongoing maintenance of the Quality Management System by revising SOPs, work instructions, and forms as assigned. Coordinate training and assist in development of training materials working directly with the site Training Specialist. Promotes Awareness of Quality and Regulatory requirements.

　　Support Quality Engineers in the hosting and execution of Material Review Board (MRB) meetings and activities.

　　Coordinate and Investigate identified Nonconformances. Generates Non-conformance Reports (NCRs) Document the investigation, affected lots/materials/processes, and any necessary escalations, and determine the required approvers.

　　Complete Corrective Action and Preventive Action (CAPA) tasks as assigned, and support other Quality Engineers in CAPA Coordination. Conduct and document investigations, participate in Root Cause Analysis, document corrective / preventive actions, document verification of effectiveness of corrective and/or preventive actions.

　　Facilitate post-market surveillance activities, including complaint investigations and maintaining the complaint handling system. Perform and coordinate investigations including product returns, Device History Record (DHR) review, risk review, etc., in a timely manner.

　　Meet Key Performance Indicator (KPI) targets for NCRs, CAPAs, Complaints and other site quality metrics.

　　Supports local Manufacturing Quality team and Design Assurance team in maintaining Design History File (DHF).

　　Assist in hosting internal audits according to approved schedule, or external audits (e.g., FDA Inspections and MDSAP / ISO 13485 surveillance audits with Notified Body)

　　Assist in regulatory submissions as required.

　　Support and participate in material inspection and test activities, including development of inspection tools and aides, i.e., go/no go gages, visual standards, and reference samples.

　　Review and approve first article inspections to determine compliance to specifications.

　　Maintain Statistical Process Control (SPC) database and other data to support monitoring and measurement of production processes.

　　Review sterilization test results for final product release and complete work order review / DHR review for closure. This includes but is not limited to EO residuals sterility and bacterial endotoxins (pyrogen).

　　Assist Quality Engineers with data-gathering activities to support validations and/or studies.

　　Maintain acceptable standards for attendance and work overtime as needed.

　　Job Qualifications

　　Required:

　　Bachelors’ degree or equivalent in an engineering discipline is required.

　　Knowledge of 21 CFR Part 820, 93/42/EEC Medical Devices Directive, SOR 98/282 Canadian Medical Device Regulations, ISO 13485, ISO 14971, and any other medical device industry international standards.

　　High level of proficiency in Microsoft Word, Outlook, Excel, and PowerPoint required.

　　This is an on-site position in Redmond, WA with the option to work from home up to two days per week. Normal business hours are 8:00 AM to 5:00 PM. Some travel may be required (less than 5%). Some overtime will also be required.

　　Preferred:

　　Biomedical Engineering highly preferred, Bioengineering, Mechanical Engineering, etc. with relevant educational experience for medical device industry also preferred.

　　Evidence of continued learning efforts a plus.

　　Minimum of 0 – 2 years’ experience operating in any Engineering position, preferably Quality Engineering in a highly regulated manufacturing environment (medical devices, biotech, pharmaceuticals, etc.) is optimal.

　　Formal education developing problem solving skills, analytical skills. Specific tolls such as process mapping, histograms, FMEA, Cause and Effect Diagrams, etc. preferred.

　　Visio skills desirable. Experience with statistical analyses such as Minitab software a plus.

　　High level of verbal and written communication skills. Must demonstrate ability to generate technical reports and make presentations to management on a regular basis.

　　Must possess a baseline working knowledge of physics, chemistry, mechanical assembly, equipment calibration, and technical writing.

　　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 $64,375.00 - $86,906.00 / 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) || Washington (US-WA) || Redmond || Quality & Regulatory Affairs (QA/RA)