Quality Engineer

Quality Engineer IIThe 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. Work with problems of moderate 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 ResponsibilitiesCollaborate in the development and qualification activities for new and existing productsCollaborate in the development of testing and inspection methodology and documentation for new and existing productsCollaborate on Quality Objective teamsDesign and install QC process sampling systems, procedures, and statistical techniquesDesign or specify inspection and testing mechanisms and equipmentPerform failure analyses and defect investigationsAnalyze production limitations and standardsRecommend revision of specificationsInterface with other engineering departments within the company, customers, and suppliers on quality related issuesCollaborate in the development of standard operating proceduresFacilitate and perform internal auditsAdhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and proceduresUnderstand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the CompanyEnsure other members of the department follow the QMS, regulations, standards, and proceduresPerform other work-related duties as assigned*Indicates an essential function of the rolePosition QualificationsMinimum education and experience: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.Additional qualifications:Familiarity with QSR, ISO and other applicable regulations and laws requiredEngineering experience in a manufacturing environment recommended, medical device industry preferredExcellent verbal, written, and interpersonal communication skillsProficiency with MS Word, Excel, and PowerPointWorking ConditionsAnnual Base Salary Range: $85,000 to $114,000Location: Roseville, CAWe offer a competitive compensation package plus a benefits and equity program, when applicable.Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.General office, laboratory, and cleanroom environmentsPotential exposure to blood-borne pathogensRequires some lifting and moving of up to 25 poundsMust be able to move between buildings and floors.Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.Must be able to read, prepare emails, and produce documents and spreadsheets.Must be able to move within the office and access file cabinets or supplies, as needed.Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.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, 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 see Penumbra's AAP Policy Statement.