Penumbra, Inc. · 1 day ago
Quality Engineer III
Penumbra is a global healthcare company focused on innovative therapies. The Quality Engineer III will develop and implement quality system elements to ensure product quality and compliance with regulations while collaborating on testing methodologies and facilitating internal audits.
Medical Device
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
Qualification
Required
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
Familiarity with QSR, ISO and other applicable regulations and laws required
Excellent verbal, written, and interpersonal communication skills required
Proficiency with MS Word, Excel and PowerPoint required
Preferred
Leadership skills desired
Benefits
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
Paid sick time in compliance with applicable law(s)
Company
Penumbra, Inc.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies.
H1B Sponsorship
Penumbra, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (36)
2024 (42)
2023 (46)
2022 (43)
2021 (36)
2020 (26)
Funding
Current Stage
Late StageRecent News
Med-Tech Innovation
2024-05-05
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