Quality Engineer II – Catheters
Penumbra
Opportunity published from Lever · applications stay with the original hiring source.
Source verified 6 hours agoThe original job page was active during UpVagas' latest lifecycle check.
About the opportunity
The Quality Engineer II develops and implements appropriate quality system elements to ensure the high-quality level of new and existing products as well as their compliance with applicable regulations and standards.
You will work with problems of moderate scope where the analysis of situations or data requires a review of identifiable factors. You will exercise judgment to determine appropriate action and communicate and implement quality objectives.
Key responsibilities
- Collaborate in the development and qualification activities for new and existing products.
- Collaborate in the development of testing and inspection methodology and documentation for new and existing products.
- 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 and recommend revision of specifications.
- Interface with engineering departments, customers, and suppliers on quality-related issues.
- Facilitate and perform internal audits and adhere to the Company’s Quality Management System (QMS).
Qualifications
- Associate’s or Bachelor's degree in Engineering, a Life Science or a related field, with 2+ 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.
- Engineering experience in a manufacturing environment recommended, medical device industry preferred.
- Excellent verbal, written, and interpersonal communication skills.
- Proficiency with MS Word, Excel, and PowerPoint.
Annual Base Salary Range
- $85,000 to $114,000.
- Competitive compensation package plus a benefits and equity program, when applicable.
Job details
- Location: Roseville, CA.
- Working conditions include general office, laboratory, and cleanroom environments with potential exposure to blood-borne pathogens.
- Requires lifting and moving up to 25 pounds, moving between buildings and floors, and extensive computer and office equipment use.
Additional information
- Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
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