Senior Quality Engineer

Working Location: Washington, Seattle 

Workplace Flexibility: Onsite

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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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.

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Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus.

 

 

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 Engineer 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

• 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/development 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 the 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 in leading and developing 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 resolutions 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, but not limited to: Validation, Deviation, Data Trending, CAPA, Audits, etc.
• Lead and participate in the CAPA process as required, serving as a CAPA Owner or Coordinator.
• Monitor product and process performance metrics and act upon trends with minimal guidance.
• Author, collaborate on, and approve Quality System documentation, including change orders for DHF, DMR, DHR, labels, and labeling.
• Support Supplier Quality Engineering in resolving Quality issues, providing information to and interfacing with suppliers as required.
• Develop and drive measurable Quality improvements relating to products, processes, 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 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.
• Perform other duties as needed.

Job Qualifications

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. 
• Viewed as an expert in the quality field. Leaders