Senior Quality Assurance Specialist

hace 4 semanas


Caimito Barrio, Puerto Rico Penumbra A tiempo completo
Job Summary

We are seeking a highly skilled Senior Quality Engineer to join our team at Penumbra, Inc. in Alameda, CA. As a key member of our quality team, you will be responsible for ensuring the highest quality standards in our commercial manufacturing of interventional medical devices.

Key Responsibilities
  • Provide technical guidance and support to operations and commercial product manufacturing teams
  • Lead and participate in project teams to develop and continuously improve products
  • Design and implement methods and procedures for inspecting, testing, and evaluating equipment
  • Develop and validate measurement methods
  • Support developmental projects in quality assurance and quality engineering
  • Perform statistical analysis and determine responsibility for products or materials that do not meet required standards and specifications
  • Support NCRs and CAPAs as necessary
  • Support activities during FDA inspections, FDB inspections, and notified body audits
  • Participate in the development of standard operating procedures
  • Prepare documentation for inspection/testing procedures
  • Perform responsibilities required by the Quality System and other duties as assigned
Requirements
  • Bachelor's degree in Engineering, a Life Science, or a related field with 5+ years of relevant experience, including experience in Quality Engineering (QE) and ISO
  • QE production and/or operations support experience preferred
What We Offer

We offer a collaborative teamwork environment where learning is constant, and performance is rewarded. You will have the opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases. Our benefits package includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, 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).

About Penumbra

Penumbra, Inc. is a global healthcare company focused on innovative therapies. We design, develop, manufacture, and market novel products and have a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. We sell our products to hospitals and healthcare providers primarily through our direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets.



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