Quality Engineer III (Medical Device)

Job Description

General Summary

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.

Specific Duties and Responsibilities

• 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.

Position Qualifications

Minimum education and experience :

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

environment, or equivalent combination of education and experience

Additional qualifications :

Working Conditions

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.

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.

What We Offer

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.