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Sr. Quality Engineer - Catheter Manufacturing

Company: Lawinger Consulting Inc.
Location: Santa Clara
Posted on: November 19, 2021

Job Description:

Sr. Quality Engineer - Catheter Manufacturing Sr. Quality Engineer - Catheter Manufacturing
Santa Clara, CA 95054
Fulltime - Direct Hire Position Overview: Our client is seeking a direct-hire Sr. Quality Engineer in the bay area to support catheter manufacturing and work cross-functionally to resolve technical problems. Participates in decisions on scope of work, risk management, design changes, process improvements, material disposition, and implementation of revised specifications. Provides and develops solutions to broad problems, accomplishes complex assignments, develops protocols for design, and/or process activities, (including those related to verification or validation activities), determines criteria and subsequently generates summary (or final) reports. Essential Job Functions:
--- Responsible for developing, applying, revising, and maintaining quality standards for processing materials and sub-assemblies into partially or finished products.
--- Designs and implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment.
--- Analyzes nonconformance reports and returned products and recommends corrective action.
--- Prepares documentation for inspection/testing procedures, development studies, validation protocols and reports, quality plans, product defect investigations and inspection plans. Must be able to write a technical document with sufficient clarity, detail and correctness to be submitted for regulatory review with confidence. Must be able to review and provide value-added feedback to others writing such documents.
--- Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
--- Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria. Provides guidance to manufacturing and development engineers regarding documentation, process controls, data feedback systems, and best quality practices.
--- Independently performs most assignments with an understanding of the overall expectations. Receives technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects.
--- Plans, schedules, conducts, and coordinates detailed phases of engineering work in part of a major project.
--- Performs work which involves conventional engineering practice but may include a variety of complex features such as conflicting design requirements, unsuitability of conventional materials, and difficult coordination requirements.
--- Work requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of related specialties. Familiarity with FDA guidance documents and ISO and ASTM standards related to quality and medical device industry is an asset.
--- Independently assesses if components, sub-assemblies, products meet specification and can initiate, investigate and resolve non-conformances by working in conjunction with a multi- disciplinary team.
--- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
--- Responsible for participating in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes, and ensure the process has adequate and appropriate process controls. Responsible for participating and/or taking lead role in developing the risk management plan for new projects transitioning into manufacturing. (Hazard assessment, design trace matrix development, DV&V testing, and FMEA).
--- Practices company safety, quality policies and procedures, and actively requires conformance.
--- May conduct internal and supplier audits. Certified as a lead auditor in ISO13485:2016 would be an asset. Familiarity with IEC 60601 and IEC 62304 is an asset.
--- Processing, investigating, and completing customer complaints, which could require direct email responses to customers.
--- Composes technical complaint reports timely and accurately based on reported information and device investigation data.
--- May technically supervise or coordinate the work of engineers, technicians, and others who assist in specific assignments.
--- Other duties as assigned. Requirements:
--- BS in a related engineering discipline and 5+ years of related experience; or MS in a related engineering discipline and 3+ years of related experience
--- Experience in the medical device industry is strongly preferred
--- Strong technical writing skills are required
--- Experience in customer complaint investigations and complaint report writing
--- Experience in manufacturing support as a Quality Engineer
--- Must be proactive, self-motivated, and work independently with minimal supervision
--- Experience with balloon catheters and electrical systems is strongly preferred
--- Experience in completing Medical Device Reports (MDR) and Vigilance (MDV) submissions is an asset.
--- Experience in writing and reviewing design verification and validation protocols
--- Preferred experience in generating documentation and criteria for validation of manufacturing line transfer to alternative sites
--- Knowledge of statistics and minitab, including process capability and data normality assessments, analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance interval assessments for variable and attribute data, design of experiment (DOE), and variable and attribute sampling plan applications
--- Certification and/or license in a specific discipline would be an asset
--- Certified Quality Engineer would be an asset
--- Must be willing to travel up to 10% of the time
--- Effective communication skills with all levels of management and organizations
--- Operate independently and adaptability to changing requirements
--- Ability to work in a fast-paced environment, managing multiple priorities

Keywords: Lawinger Consulting Inc., Santa Clara , Sr. Quality Engineer - Catheter Manufacturing, Engineering , Santa Clara, California

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