Senior Quality Engineer

Job Description Develop, maintain, and support the company Quality System regulatory requirements and business strategy. Continuously improve quality performance related to manufacturing and metrics related to the strength of the site Quality System. Leads complex projects. Mentors Quality Engineers for best practices for the use of quality tools and methods. Can serve as a backup to the Management Representative for the site. Job Duties Leads and participates in cross‑functional teams to support manufacturing representing the Quality Engineering discipline. Completes assigned Quality Engineering tasks on schedule. Leads or participates in the development of process and procedure changes. Provides resident expertise in the application of quality sciences including statistics, data analysis, problem solving and the creation of system solutions. Develops, maintains and reviews product risk management files, and provides guidance on application of risk management to quality system processes (FMEAs, NCR risk, CAPA risk, etc.). Develops new approaches to solve problems identified as part of the team. Assists others to lead and develop novel approaches within the quality team. Leads the implementation, compliance, and maintenance of standards (e.g., FDA CFR Title 21 Trains location personnel on all aspects of the quality system and regulatory standards. Serves as a mentor and advisor for the quality team to assist in developing quality engineering skills and capabilities. Applies the requirements of the quality system to processes, products, or services for the location. Leads, supports, and guides the manufacturing line to address quality issues and resolution using the best quality techniques and principles. Develops and maintains the validation and verification strategy for new and existing products and processes. Leads quality system elements such as, but not limited to, validation, deviation, data trending, CAPA, and audits. Leads and participates in the CAPA process as required as a CAPA Owner or Coordinator. Monitors product and process performance metrics and acts upon trends with minimal guidance. Authors, collaborates, and approves quality system documentation including change orders for DHF, DMR, DHR, labels and labeling, etc. Supports Supplier Quality Engineering to resolve quality issues, providing information to and interfacing with suppliers as required. Develops and drives measurable quality improvements relating to products, process, and services. All other essential related duties as required. Supports verification, validation, calibration, and preventive maintenance activities. Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to cross‑functional teams and management. Runs reports to analyze production and complaint data and identify any significant trends. Supports the quality management system (QMS) by performing periodic product, process, and internal audits. Performs other duties as needed. Job Qualifications Bachelor’s degree in engineering discipline or equivalent. Master’s degree preferred. Minimum of 5 years related experience preferably in the medical device industry related to process/quality engineering. Viewed as an expert in the quality field. Leadership experience: proven ability to lead and manage cross‑functional teams, effectively communicate with all levels of management and drive effective change. Background and familiarity with regulatory requirements and international standards, including U.S. FDA QSR requirements, EU MDR 2017/745, Canada medical device requirements, ISO 13485:2016, and ISO 14971:2019, and the ability to educate others on related subject matter. Strong quality science skills including demonstrated statistics application and problem solving. Excellent verbal and written communication skills demonstrated by ability to generate technical reports and make presentations to middle and upper management. Proven project management skills with ability to manage cross‑functional team and produce results. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization and/or guidance exists. Working knowledge of problem‑solving tools and root cause analysis techniques (i.e., FMEA, Pareto analysis, cause & effect diagrams, 5‑whys, Ishikawa diagrams, etc.). Benefits and Culture 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. 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. Location and Flexibility Working location: Washington, Redmond. Workplace flexibility: Hybrid. Workplace flexibility: Hybrid. Equal Employment Opportunity Statement 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. 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. If reasonable accommodation is needed, please contact View email address on click.appcast.io. If your disability impairs your ability to email, you may call our HR Compliance Manager at 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), gender identity and expression, sexual orientation, marital status, disability (physical or mental), 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