Principal 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

The Principal Quality Engineer is responsible for developing, maintaining, and supporting the company's Quality System, regulatory requirements, and business strategy. Continuously improve Quality performance related to New Product Development, procurement, manufacturing, and metrics related to the strength of the site's Quality System. Leads complex projects. Mentors for less experienced engineers within and across OSTA sites in best practices for the use of Quality tools and methods. Expected to serve as a backup to the Management Representative for the location.

Job Duties

• Leads and participates in Cross-Functional Teams to support new product development, procurement, and manufacturing, representing QualityEngineering discipline.
• Completes assigned Quality Engineering tasks on schedule.
• Leads the promotion of Quality and Regulatory requirements.
• Leads or participates in the development of processes and procedures development/changes.
• Provides resident expertise in the application of QualitySciences, including statistics, data analysis, problem solving, and the creation of systems.
  solutions.
• Develops new approaches to solve problems identified as part of the team.
• Assists others in leading and developing novel approaches within the 5E teams.
• Leads the implementation, compliance, and maintenance of standards (e.g., FDA, ISO13485) and OGA Quality policies and procedures for the site.
• 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 the development and maintenance of Master Validation Plans.
• Participates in the CAPA process as required as an assignee or project team member.
• Monitors product and process performance metrics and acts upon trends with minimal guidance.
• Authors, collaborates, and approves Quality System documentation, including change orders, DHF, DMR, DHR, labels, and labeling, etc.
• Conducts internal, vendor, and process audits on schedule.
• Interfaces with suppliers to resolve quality issues.
• Develops and drives measurable quality improvements relating to products, processes services.
• All other essential related duties as required

Job Qualifications

Required:

• Bachelor's degree in engineering discipline or equivalent. Master's Degree preferred.
• Minimum of 8 years of 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.
• Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD93/42, ISO 13485-2003 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 ability to generate technical reports, and abili