Senior Quality Engineer

Working Location

Washington, Redmond

Hybrid

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 and mentors Quality Engineers on best practices for the use of Quality tools and methods. Can serve as a backup to the Management Representative for the site.

• Lead and participate in cross-functional teams to support manufacturing representing the Quality Engineering discipline.
• Complete assigned Quality Engineering tasks according to schedule.
• Lead or participate in the development of process and procedure changes.
• Provide resident expertise in the application of Quality Sciences including statistics, data analysis, problem solving and the creation of system solutions.
• Develop, maintain and review product risk management files, and provide guidance on application of risk management to Quality System processes (FMEAs, NCR risk, CAPA risk, etc.).
• Develop new approaches to solve problems identified as part of the team.
• Assist others to lead and develop novel approaches within the Quality team.
• Lead the implementation, compliance, and maintenance of standards (e.g., FDA CFR Title 21 §820, ISO 13485, ISO 14971) and Olympus Global Quality policies and procedures for the sites.
• Train location personnel on all aspects of the Quality System and regulatory standards.
• Serve as a mentor and advisor for the Quality team to assist in developing Quality Engineering skills and capabilities.
• Apply the requirements of the Quality System to processes, products, or services for the location.
• Lead, support, and guide the manufacturing line to address quality issues and resolution using the best Quality techniques and principles.
• Develop and maintain the validation and verification strategy for new and existing products and processes.
• Lead Quality system elements such as validation, deviation, data trending, CAPA, audits, etc.
• Lead and participate in the CAPA process as required as a CAPA Owner or Coordinator.
• Monitor product and process performance metrics and act upon trends with minimal guidance.
• Author, collaborate, and approve Quality System documentation including change orders for DHF, DMR, DHR, labels and labelling, etc.
• Support Supplier Quality Engineering to resolve Quality issues, providing information to and interfacing with suppliers as required.
• Develop and drive measurable Quality improvements relating to products, process, and services.
• Support verification, validation, calibration, and preventive maintenance activities.
• Communicate significant issues or developments identified during Quality assurance activities and provide recommended process improvements to cross-functional teams (CFTs) and management.
• Run reports to analyze production and complaint data and identify any significant trends.
• Support the Quality Management System (QMS) by performing periodic product process and internal audits.

Required

• 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.
• View 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 ability to 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…