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LCI-Lawinger Consulting Sr. Quality Engineer in Santa Clara, California

This a second shift quality engineering position (2:30-10:30 PM); all work is done onsite ? no remote work. Strong independent decision making and work autonomy skills necessary due to second shift nature or position.

Position Overview: Participates in decisions on the scope of work, risk management, design changes, material disposition, and implementation of revised specifications. Provides and develops solutions to broad issues, develops protocols for design, and/or process activities (including those related to verification or validation activities). May provide technical guidance to lower-level personnel.

Essential Job Functions:

  • Responsible for developing, revising, and maintaining quality standards for processing materials/products into partially or finished products.

  • Designs and implements procedures for inspecting, testing, and evaluating the precision and accuracy of products, components, sub-assemblies, and/or production equipment.

  • Analyzes non-conformance 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.

  • Provides guidance to manufacturing and development engineers regarding documentation, process controls, data feedback systems, and best quality practices..

  • Work requires a broad knowledge of of company product and knowledge of principles and practices of related technical specialties.

  • Familiarity with FDA guidance documents and ISO and ASTM standards related to quality and the medical device industry necessary.

  • 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 a lead role in developing the risk management plan for new projects (Hazard assessment, design trace matrix development, DV&V testing, and FMEA)

  • Ability to coordinate the work of engineers, technicians, and others who assist in related assignments

  • May conduct internal and supplier audits. Familiarity with IEC 60601 and IEC 62304

    • Apply knowledge of statistics and Minitab, including process capability and data normality assessments, analysis of variance, hypothesis testing, design of experiment (DOE), and variable sampling plan applications
  • Write and review design verification and validation protocols

Required Experience:

  • BS in a related engineering discipline; and 5?8 years of related experience; or MS in a related engineering discipline and 4?6 years of related experience

  • Ability to write technical documents with sufficient clarity, detail, and correctness to be submitted for regulatory review with confidence

  • Experience in the medical device industry strongly preferred

Additional Preferred Experience:

  • Certification and/or license in a specific related discipline

  • Certified Quality Engineer preferred

  • MiniTab experience preferred

  • Certification as a lead auditor in ISO13485:2016 desirable