Quality Engineer

Quality Engineer

Location: Los Gatos, CA

Job type: Fulltime

Technical/Functional Skills

· Quality Engineering working knowledge and Quality Management Experience

· Working knowledge of ISO, MDD, FDA QSR 21 CFR 820 / ISO 13485 quality system requirements and the ability to provide an expert knowledge of both regulatory requirements and other compliance areas to minimize risk across product lines

· Strong working knowledge of ISO 14971 Risk Management Process (System Risk Analysis, DFMEA/FMEA and other Risk Management tools)

· Extensive design/sustaining quality experience within medical device industry.

· New product development and post launch support activities, Product remediation and risk management activities

· Working knowledge of Microsoft office products (MS Word, Excel) and Statistical Analysis Software tools

· Writing protocol and reports for design and product validation, and execution

· Engineering change order

· Development of a Standard Procedure (SP), related Work Instructions (WI), Forms, Checklists for design verification and validation activities.

Roles & Responsibilities

· Ensure robust technology transfer to products from the development stage to post launch/operations

· Support the development of product, process and packaging requirements in that are complete, compliant and effective

· Ensure product, systems and processes are current in relation to global regulatory requirements

· Work with Core Teams and development partners to ensure robust design quality practices are embedded and applied

· Work with Quality Engineers and project teams to ensure the continued application of Risk Management principles in the post-launch environment

· Partner with Reliability Engineering to ensure that robust design reliability practices are embedded and applied

· Define the controls and quality standards for new products and design changes

· Identify opportunities to continuously improve quality, cost and time factors, consistent with business objectives

· Provide constructive technical challenge to R&D and other technical functions to drive better team performance and project outcomes

· Support organizational development and improvement of the quality system

Education

· Mechanical/Electro Mechanical/ Electrical/Bio-medical Engineering

· Preferred Education: Master's Degree or Ph.D.