Quality Assurance Engineer II- Product Stewardship

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about 2 years old

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In this exciting Quality Assurance Engineer II role, you will play a key role in cross-functional teams to ensure Global Chemical Compliance and Product Stewardship. You will have the opportunity to assist in creating 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 Penumbra’s fast paced growth and help us ensure regulatory compliance to allow products to reach more patients!

What Success Looks Like

  • Assist in identifying Quality Systems and business processes to be implemented based on regulation requirements.
  • Work on projects to learn and ensure compliance to chemical regulations, such as REACH, CLP, RoHS, TSCA, Prop 65, and EU MDR CMR/ED and others as needed.
  • 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.
  • You will effectively communicate with cross functional teams to execute on compliance projects and ensure they meet appropriate business timelines. 
  • With active listening and attention to detail, you will work with internal departments 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 1+ years of industry experience or an equivalent combination of education and experience required.
  • Strong organizational and project management traits and experiences.
  • Solid examples problem-solving, decision-making, and leadership skills required.
  • Proficiency with online data bases, data management, ERP systems, Microsoft Office Suite 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 Penumbra’s Privacy Notice for California Residents.