Quality Engineering Manager--Medical Device

Company: Talent Finders, LLC
Location: Escondido
Posted on: February 19, 2021

Job Description:

Fast Growing Medical Device Manufacturing Operation in Escondido seeks a Senior Level QE to join its team.
The Senior Quality Engineer/Quality Engineering Manager will be responsible for all QC/QA functions for the Escondido Machining Plant. This will include developing inspection procedures, managing the Calibration Function, and contributing to a larger number of NPI Projects.
Essential Job Duties and Responsibilities:
--- Manage the Quality Engineering department for the Escondido facility, ensuring product quality and operational goals are met.--- Initiate and implement programs aimed at improving the quality of operations and reducing the total cost of quality.--- Develop quality plans, inspection processes, and sampling procedures. This includes validation of inspection methods and equipment as required.--- Provide oversite for programming of complex automated inspection equipment.--- Support Quality Control and Complaints department by performing product evaluations for the most complex or unclear product discrepancies.--- Provide training to Quality Control and Operations personnel on inspection methods.--- Assist with tracking and trending of nonconforming products, complaints, efficiencies, and other key metrics.--- Manage the calibration department, ensuring the company is always in compliance with the calibration program and responsibility for properly conducting calibration of gages, either in house or through external suppliers.--- Responsible for the acquisition, maintenance, and disposal of all company measurement devices, gages, and equipment.--- Provide quality support for new product development projects. This includes drawing reviews, product and process risk assessments, and validation execution.--- Job duties are not limited to the areas of responsibility listed above. Specific responsibilities may be modified and additional responsibilities may be assigned which are in line with the job summary at the discretion of company management.
Education, Experience, Skills, & Abilities: --- --- Bachelor's degree in Engineering or related field is required, 5+ years of experience in Medical Device industry serving in Quality or Engineering.--- Have a working knowledge of the FDA Quality System Regulations and Design Control Requirements.--- Have a working knowledge of 21 CFR 820 (Quality System Regulation for Medical Devices), ISO 13485 (Quality Management Systems - Requirements for Regulatory Purposes), and ISO 14971 (Medical Devices - Application of risk management to medical devices).--- Ability to communicate and interact with senior leadership, produce and deliver presentations to a wide range of audiences.--- Strong problem solving, critical thinking, analytical skills, organization and professionalism. Experience in the use of root cause analysis tools.--- Ability to prioritize and plan effectively.--- Highly motivated with demonstrated ability to work independently with minimal supervision.--- Demonstrated ability to lead others.--- Demonstrated/practical application of Statistical methods, quality tools, and methodologies.--- Able to read and understand mechanical drawings using ASME Y14.5.--- Proficient with statistical analysis tools (Minitab or JMP), and high level skills working with Microsoft Excel, Microsoft Word and Microsoft PowerPoint.--- ISO auditing experience is a plus.--- Lean, Six Sigma Green or Six Sigma Black Belt Certification desirable.--- ASQ Certification preferred, but not required.

Keywords: Talent Finders, LLC, Escondido , Quality Engineering Manager--Medical Device, Executive , Escondido, California