**Senior Quality Assurance Engineer- Product Stewardship**
Alameda, CA / Engineering / External In this exciting and demanding Senior Quality Assurance Engineer role, you will play a key role in cross-functional teams to ensure Global Chemical Compliance and Product Stewardship. You will help lead a department of Quality Assurance Engineers, and create steady operations to manage processes that ensure worldwide material and chemical compliance. In this pivotal role, you will have the opportunity to establish a critical business function that ensures human and environmental safety around the globe. Be a part of Penumbras fast paced growth and help us ensure regulatory compliance to allow products to reach more patients! **What Success Looks Like**
+ With your history of implementing Quality Systems or business processes, partner with Compliance SMEs to assist in identify systems/processes to be implemented based on regulation requirements.
+ Manage projects to ensure compliance to chemical characterization regulations, such as REACH, CLP, RoHS, TSCA, Prop 65, and EU MDR CMR/ED.
+ Work with external consultants on campaign efforts to obtain material information from suppliers and supply chain.
+ Work directly with suppliers on obtaining material and chemical information and resolve any issues that may arise.*
+ Manage online data base of material information and optimize for accuracy and performance.
+ Through thoughtful teamwork, you will assist in the development 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.
+ You will stay up-to-date 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 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 3+ years of experience or equivalent in Material Science/Engineering, Regulatory Compliance, Supplier Quality, 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 and others as needed.
+ Strong organizational and project management traits and experiences.
+ Solid examples problem-solving, decision-making, and leadership skills required.
+ 2+ years of industry experience (e.g. medical device, life science, pharma, chemical manufacturing/distribution, EH&S, waste management and compliance).
+ Proficiency with online data bases, data management, ERP systems, Microsoft Office Suite preferred.
+ Exposure and understanding of Chemical Regulatory Global Compliance, ISO standards, and the MDD/MDR preferred.
+ Strong oral, written, and interpersonal skills preferred
+ Experience with medical device industry nice to have.
**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 .
