Senior Quality Engineer

Company: The Judge Group
Location: Los Altos
Posted on: November 22, 2021

Job Description:

Location: Los Altos, CA Description: What we want:- An individual that provides quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes.- Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers.- Ensure compliance to regulation and standards.- Strong understanding of manufacturing process and process control.- Technical understanding of manufacturing prints and tolerances.The Senior Quality Engineer serves a key role for remediation and integration activities for both sustaining and merger & acquisition (M&A) quality support at Client. As a leader in achieving staggering growth through M&A and R&D, Client continues to set the pace to successfully integrate and bring disruptive technologies to operating rooms all over the world, every day.The Senior Quality Engineer interfaces with many functions of the business, both internal and external, including, sourcing, regulatory, and operations, ensuring that the products and services provided by our global supply base continue to meet and exceed customer needs. What you will do: - Work closely with operations and the business functions to ensure quality performance of product and processes.- Develop and implements methods ad procedures for process controls, process improvements, testing and inspection to ensure the products are free of flaws and functions as design.Key Areas of Responsibility: - Lead quality system maintenance by identifying and correcting deficiencies in procedures and practices.- Design and/or implement methods and procedures for inspecting, testing and evaluating the precision and reliability of products and/or production and/or test equipment. This includes but is not limited to: Statistical process controls, incoming part/in process, and final inspection criteria, MSA, etc.- Prepare or modify documentation for inspection/testing procedures.- Design and/or specify inspection/testing procedures.- Own identified In-house non-conformances and manage the timely closure of NC's within Trackwise. Own or support identified supplier CAPAs and manage to timely root cause investigation, implementation and closure.- Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, take action as necessary.- Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc.- Analyze and define critical quality attributes for product and process through risk analysis techniques.- Develop and review of process and equipment validation/qualifications. Build proficiency in validation processes.- Collaborates with supplier quality for in house supplier quality issues.- Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.Basic Qualifications:- Bachelor---s Degree- 3+ years' experience in quality, engineering, manufacturing, or highly regulated environment- Good Knowledge GMP, ISO 9001, ISO13485, CFR820 or comparable industry standards and regulatory requirements.- Computer literacy.- Good knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment. Preferred Qualifications:- Bachelor---s Degree in Engineering or Science-related field- CQE- Understanding of US, EU and International Medical Device Regulations.- Strong knowledge of Quality Concepts (e.g. Risk Management, NC/CAPA, Audits, Statistics).

Keywords: The Judge Group, San Francisco , Senior Quality Engineer, Engineering , Los Altos, California