Quality Engineering Manager

Working Location: CALIFORNIA, SAN JOSE 

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.

 

**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

 

 

Job Description

Oversee management responsibilities for Quality Engineers. Responsibilities to include, leadership and guidance; employee planning, and assigning work direction. May serve as a site Management Representative, as delegated. Manage the execution of activities to ensure compliance with the OSTA and local Quality Systems, Regulatory requirements, and the business strategy of the company. Leads Quality Projects and CAPAs. Supports and leads Change Orders, as needed. This position reports into the Director of Quality, San Jose Operations.

Job Duties

• Promotes awareness and compliance to all relevant Quality and Regulatory requirements across the site. Ensures that adequate equipment and supplies are provided, where needed, And for appraising job results, including Quality related Productivity and Efficiency. 
• Supports operations to assist the efficient processing of Change Orders and processing of medical devices through their processes. 
• Applies the requirements of the Quality System to processes, products or services for the site. 
• Ensures that inspections occur effectively and efficiently. 
• Manages calibration for equipment used by the site (overall but including quality, timeliness, and cost). 
• Ensures that Preventive Maintenance activities are performed for Quality equipment. 
• Manages audit preparedness, including internal audits and third-party audits. 
• Responsible for the compliance of the NCR process (including the timeliness and completeness of actions taken) Leads MRB to ensure proper and timely disposition of non-conforming product (NCRs) 
• Ensures that metrics are provided for management review (CAPA Board, formal Quality Systems 
• Management Reviews, etc.). 
• Communicates significant issues to site senior management and corporate management and ensures that plans for correction are developed. 
• Take actions to achieve and maintain goals related to audit results (no Majors, etc.). 

Job Qualifications

Required:

• A 4-year degree in Engineering or other related science required. 
• Minimum of five (5) years experience in the Medical Device industry where the individual was responsible for ensuring either improved product quality, improved Quality compliance, or both with responsibility for others' compliance, timeliness, and/or efficiencies.  
• Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, and ISO 13485. 
• Travel up to 10% of the time.
• All other essential related duties as required.

 

Preferred:

• Strong working knowledge of problem solving skills. 
• Excellent verbal and written communication skills demonstrated by ability to generate technical reports, and ability to make presentations to middle and upper management. 

Why join Olympus?

 

We offer a holistic employee experience supporting personal and professional well-being through meaningful