Penumbra, Inc. · 10 hours ago
Quality Engineer III
Penumbra, Inc. is a global healthcare company focused on innovative therapies and the development of life-saving medical devices. The Quality Engineer III will support Commercial Operations to ensure high-quality manufacturing of Class II/III interventional medical devices by executing quality actions, collaborating with teams, and providing guidance to junior engineers.
Medical Device
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
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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