Quality Engineer III

You will have an opportunity to identify and own high impact projects to life saving medical devices. In this opportunity, you will independently support Commercial Operations to ensure the high-quality manufacturing of Class II/III interventional medical devices. This position will provide work with problems of advanced scope where the analysis of situation or data requires a review of identifiable factors. Work with collaborative teams to exercise good judgment to determine appropriate quality actions, and communicate and implement quality objectives.

•Support Commercial Operations and Manufacturing activities such as Incoming/In-process/Final Inspections, NCRs, CAPAs, Engineering Change Orders, Control Chart Investigations, Deviation Authorizations, and Equipment sustaining activities.

•Support assigned manufacturing product lines and perform failure analyses and defect investigations as appropriate. 

•Execute and collaborate on Continuous Improvement efforts.

•Execute and support supplier activities such as Second Source Qualifications, Supplier Changes, and SCARs. 

• Interface with other engineering departments within the company, and suppliers on quality related issues.

• Collaborate and/or help lead in the development of manufacturing documentation. 

• Design, improve and support Test Methods, Testing Equipment and TMVs. 

• Recommend revisions to specifications, acceptance criteria, and manufacturing documentation to improve quality of product and/or Manufacturing Operations.

• Provide guidance to junior Quality Engineers in support of departmental functions. 

• Perform responsibilities required by the Quality System and other duties as assigned or requested.  

•Ensure other members of the department follow the QMS, regulations, standards, and procedures.  

• Perform other work-related duties as assigned.

Minimum education and experience:

• Associate’s or Bachelor's degree in Engineering, a Life Science or a related field with 3+

years of quality engineering or relevant experience, preferably in a medical devices

environment, or equivalent combination of education and experience 

Additional qualifications: 

• Familiarity with QSR, ISO, and other applicable regulations and laws required 

• Excellent verbal, written, and interpersonal communication skills required 

• Leadership skills desired 

• Proficiency with MS Word, Excel, and PowerPoint required 

• General office, laboratory, and cleanroom environments 

• Requires some lifting and moving of up to 25 pounds

• The employee is frequently required to stand, walk, sit, and reach with hands and arms, 

and to use a computer, sitting for extended periods. Specific vision abilities required by 

this job includes the ability to read, close vision, distance vision, color vision, peripheral 

vision, and depth perception.

• Alameda, CA

• Starting Base Salary is $109,000/year to $152,000/year

The above statements are intended to describe the general nature and level of work being 

performed by people assigned to this classification. They are not intended to be construed as an 

exhaustive list of all responsibilities, duties, and skills required of personnel so classified.