Product Evaluation Supervisor

Company: Jobleads
Location: Alameda
Posted on: June 6, 2021

Job Description:

The Product Evaluation Supervisor is responsible for supervising product failure evaluations on returned products and determines technical aspects of the failure modes. Prepares and provides reports to management of findings and trends. Responsible for selection, training, scheduling and evaluation of junior engineers and technicians. What You'll Work On Coordinates scheduling and assignments of direct reports. Conducts analysis of returned product and investigates complaints that device may not meet specifications Manages and performs failure analysis of products, materials and processes to determine root cause and prevent or correct complaints, non-conformances and product failures Documents analysis and investigation findings Assesses Complaints and Post-Market Surveillance programs, policies, and procedures for compliance to domestic and international requirements Identifies opportunities for improving the current programs, processes, and procedures as may be required by changes in regulatory requirements, business plans or other changes Oversees productivity of Evaluation Lab, and identifies needs and opportunities for improvements Facilitates collaboration with the R&D and Manufacturing groups to determine FMEA rates in support of failure analyses and develop new analytical methods for failure analyses when new products are launched Coordinates interdepartmental communication and provides quantifiable data in response to the needs of each department Directs the generation of monthly trending reports and analysis of complaints and investigations by product type Conducts data queries and develops reports in association with HHE activities Supports internal and external audit activities Selects, trains, and provides ongoing feedback and mentoring, including product failure evaluations and professional growth plans for Junior Engineers, Product Evaluation Technicians, Engineering Interns and other junior staff members within the product evaluations group. What You Bring Bachelor of Science degree in engineering required with a minimum of 5 years of experience in Quality or R&D engineering in a medical device environment, or equivalent combination of education and experience. Working knowledge of FDA, international medical device and GMP regulations and standards. Prior supervisory experience preferred. Solid problem solving, decision-making, leadership skills as well as strong oral, written and interpersonal communication skills required. What We Offer A collaborative teamwork environment where learning is constant and performance is rewarded. The opportunity to be at the forefront of technology 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.

Keywords: Jobleads, Alameda , Product Evaluation Supervisor, Other , Alameda, California