Quality Specialist

Working Location: Washington, Seattle; Washington, Redmond Workplace Flexibility: Onsite Job Description This position is responsible for maintaining records and supporting day-to-day quality system activities. The primary purpose of the role is to facilitate the Quality team in the administrative aspects of work to maintain the Quality System, including scanning and filing of records, maintaining meeting and audit minutes, and change management. This is an entry level role which will provide the applicant with broad experience in a highly technical medical device manufacturing facility. Job Duties Interpret and comply with company Standard Operating Procedures, and ensure records are compliant with all procedural requirements. Support preparation of records for CAPA Review Board (CRB), Key Performance Indicator (KPI) Review, and Management Review, and facilitates the planning and execution of these reviews. Support audit preparation, execution and generation of records. May serve as an audit coordinator, scribe or other functions as assigned by Site Quality Manager. Developing and collaborating on new and/or revised processes to seize opportunities for improvement. Maintain user access to the Agile Product Lifecycle Management system by submitting Agile Access Requests, coordinating with the site Training Specialist to obtain user training records as applicable. Create documents and change orders as assigned by Site Quality Manager. Monitor Change Management process to support timely completion of change orders; support change order originators where possible and communicate priority with reviewers. Support Quality team initiatives and projects as assigned by Site Quality Manager. Job Qualifications High School Diploma required. BS degree in science or quality/regulatory preferred, or equivalent work experience. Minimum of 2 years of experience in a medical device company or equivalent regulated industry preferred. Experience in administrative roles, document control, etc. as applicable. Knowledge of Quality Management System standards (ISO 13485 and/or ISO 9001). Proven history of working independently and within teams to accomplish common goals. Ability to read, analyse and interpret Quality System documents and Records. Proficiency in Microsoft Office suite tools (Word, Excel, PowerPoint, and Outlook). Strong written and verbal communication skills are essential. Must be highly organized and detail-oriented, with the ability to maintain a constant influx of records and tasks. Typical business hours Monday – Friday, 8:00 AM to 5:00 PM. No travel required. Benefits Competitive salaries, annual bonus and 401(k)* with company match Comprehensive medical, dental, vision coverage effective on start date 24/7 Employee Assistance Program Free live and on-demand Wellbeing Programs Generous Paid Vacation and Sick Time Paid Parental Leave and Adoption Assistance* 12 Paid Holidays On-Site Child Daycare, Café, Fitness Center** Connected Culture you can embrace Work-life integrated culture that supports an employee centric mindset Offers onsite, hybrid and field work environments Paid volunteering and charitable donation/match programs Employee Resource Groups Dedicated Training Resources and Learning & Development Programs Paid Educational Assistance Equal Employment Opportunity 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. #J-18808-Ljbffr Olympus Corporation of the Americas