Quality Engineer III

Working Location: CALIFORNIA, SAN JOSE 

Workplace Flexibility: Onsite

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

 

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

 

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

 

We deliver on our purpose and our core values by staying True to Life.

Job Description

Develop maintain and support the company 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 Quality System. Leads complex projects. Mentors Quality Engineer for best practices for the use of Quality tools and methods.

Job Duties

• Leads and participates in Cross-functional teams to support new product development procurement manufacturing representing Quality Engineering discipline.
• Completes assigned Quality Engineering tasks to schedule.
• Leads or participates in the development of process and procedure/development changes.
• Provides resident expertise in the application of Quality Sciences including statistics, data analysis, problem solving and the creation of system solutions.
• Develops new approaches to solve problems identified as part of the team. Assists others to lead and develop novel approaches within the SE teams.
• Leads the implementation, compliance, and maintenance of standards (e.g., FDA, ISO13485) and OGA Quality policies and procedures for the sites.
• Train’s 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, Audits etc.
• 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 labelling etc.
• Conducts internal vendor and process audits to schedule.
• Interfaces with suppliers to resolve Quality issues.
• Develops and drives measurable Quality improvements relating to products, process, and services. All other essential related duties as required.
• Perform/Support Verification/Validation/Calibration/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.
• 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. 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 13485-2016 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 demonstra