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Quality Assurance Engineering Manager- Product Stewardship - Alameda, United States - Penumbra
Description
**Quality Assurance Engineering Manager- Product Stewardship**
Alameda, CA / Engineering / External In this exciting and demanding Quality Assurance Engineering Manager role, you will play a key role in cross-functional teams to ensure global chemical compliance and new product readiness for submissions. You will help build a department of Quality Assurance Engineers, and steady operations to manage processes that ensure worldwide material and chemical compliance. **What Success Looks Like**
+ Manage and ensure compliance to chemical characterization regulations, such as REACH, CLP, RoHS, TSCA, Prop 65, and EU MDR CMR/ED.
+ Manage external consultants on campaign efforts to obtain material information from suppliers and supply chain.
+ Manage online data base of material information and optimize for accuracy and performance.
+ Through thoughtful leadership, you will hire, train, and develop the Quality Assurance Engineering Team.
+ You will effectively communicate with cross functional teams to set priorities and develop appropriate timelines for your group.
+ With active listening and attention to detail, you will interface with internal customers to understand and define cross-functional priorities, and ensure that your team is structured to meet those priorities.
+ You will stay a breadth with all updated regulatory standards and lists, and ensure timely and effective response activities.
+ You will work directly on internal process improvements, and train others to effectively utilize these processes.
+ With clear and concise communication, you will support and defend Quality System processes during the internal, notified body, FDA, State Agency, and any other potential global regulatory body audits.
+ With your stellar initiative, you will make systems leaner and more intelligent by proactively seeking system improvements and, of course, maintaining compliance.
**What you Bring**
+ BS degree with 5+ years of experience or equivalent in Material Science/Engineering, Regulatory Compliance, Quality Assurance, Quality Engineering, Biotechnology, or a related field, or an equivalent combination of education and experience required.
+ Experience with setting up or maintaining systems in compliance with some or all combination of REACH, CLP, RoHS, TSCA, Prop 65, and EU MDR CMR/ED regulations.
+ Strong organizational and project management traits and experiences.
+ Solid examples problem-solving, decision-making, and leadership skills required.
**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 that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan 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, disability or protected veteran status.* If you reside in the State of California, please also refer to .
