Supplier Quality Engineer

at Penumbra, Inc.
Location Alameda, California
Date Posted June 22, 2022
Category Engineering
Job Type Not Specified

Description

As a member of Penumbra's Supplier Quality Engineering team, you will ensure that our outside suppliers are in compliance with all applicable regulations and standards. You will be looked to as a key resource, both internally and externally, on quality objectives, and as a technical expert in the sourcing and selection of suppliers. There is up to 25% travel with this role.
What You'll Work On

  • Participate in the materials selection, development and qualification activities for new and existing suppliers.
  • Coordinate and participate as Lead Auditor in the external supplier audit program.
  • Support supplier qualification studies.
  • Support alignment of testing and inspection methodology at Penumbra with supplier inspection/testing programs.
  • Interface with suppliers on the use of Quality Engineering methodologies, tools, quality and regulatory requirements, etc. and assist in solving day-to-day quality issues.
  • Participate in NCR or CAPA board as necessary.
  • Manage and approve the evaluation of assigned Supplier Changes and Second Sourcing projects
  • Mentor junior Supplier Quality Engineer(s) in support of Supplier Quality functions
  • Coordinate the evaluation of Supplier Corrective Action Requests (SCARs) and provide engineering support for identifying and correcting supplier related issues.
  • Participate in and support supplier-related complaint investigations.
  • Interface with other internal departments, customers, and suppliers on quality-related issues.

What You Bring

  • A passion for problem solving.
  • Bachelor's degree in a science or Engineering related discipline and 1+ year of quality engineering experience in the medical device industry.
  • In depth knowledge of the QSR, ISO 13485 and other applicable regulations and laws.
  • Experience performing supplier audits.
  • Expertise in statistical methodologies and analysis.
  • Training and experience in performing internal and external audits; certification preferred.
  • Strong oral, written, and interpersonal communication skills.
  • Ability to travel up to 25% of the time visiting and auditing suppliers.

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 .

Drop files here browse files ...