General Summary
Independently develop and implement appropriate quality system elements to ensure the high-quality level of new and existing products as well as their compliance to applicable regulations and standards. Work with problems of advanced scope where the analysis of situation or data requires a review of identifiable factors. Exercise judgment to determine appropriate action. Communicate and implement quality objectives.
Specific Duties and Responsibilities
•Collaborate and/or help lead in the development and qualification activities for new and
existing products *
•Collaborate and/or help lead in the development of testing and inspection methodology
and documentation for new and existing products*
•Collaborate and/or help lead on Quality Objective teams*
•Design and install QC process sampling systems, procedures, and statistical
techniques*
•Design or specify inspection and testing mechanisms and equipment*
•Perform failure analyses and defect investigations *
•Analyze production limitations and standards *
•Recommend revision of specifications *
•Interface with other engineering departments within the company, customers, and
suppliers on quality related issues*
•Collaborate and/or help lead in the development of standard operating procedures*
•Facilitate and perform internal audits*
•Perform responsibilities required by the Quality System and other duties as assigned or
requested *
•Provide guidance to junior Quality Engineers and interns in support of departmental
functions*
•Adhere to the Company's Quality Management System (QMS) as well as domestic and
global quality system regulations, standards, and procedures. *
•Understand relevant security, privacy and compliance principles and adhere to the
regulations, standards, and procedures that are applicable to the Company. *
•Ensure other members of the department follow the QMS, regulations, standards, and
procedures. *
•Perform other work-related duties as assigned.
*Indicates an essential function of the role
Position Qualifications
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
Working Conditions
•General office, laboratory, and cleanroom environments
•Potential exposure to blood-borne pathogens
•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 $ 109,760 to $145,920
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
•A collaborative teamwork environment where learning is constant, and performance is rewarded.
•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
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 Penumbra's AAP Policy Statement.