Staff Advanced Quality Engineer - 29537BR - EN in Kalamazoo, MI at Stryker Corporation

Date Posted: 5/13/2018

Job Snapshot

Job Description

The Sr. AQE-New Product Development & Health Hazard Assessment (NPD&HHA) will be responsible for quality system support for R&D projects; provide inputs to R&D designs from a quality perspective; work closely with R&D to develop test strategies for product designs and analyze the risk associated with these designs; provide statistical support and analysis; improve quality processes as they apply to new/existing product design; participate and provide the necessary support to the HHA process

  • Help guide R&D through our internal quality system to ensure products are developed in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies.
  • Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust products/processes.
  • Support process validation programs for new/existing product development.
  • Involved in developing, modifying, and executing regulatory related company guidelines and procedures.
  • Provide input throughout the new product development process from a quality perspective.
  • Perform risk analysis and develop mitigation strategies
  • Collaborate with Design engineers to develop robust verification test strategies to ensure safe, reliable products are implemented.
  • Educate R&D on the use of risk management tools, statistical methods, design and process control activities, and sound verification and validation test planning to help drive quality upfront in new product development.
  • Perform supplier development activities surrounding PPAP
  • Develop, create and update, as appropriate, procedures for incoming, in-process, and final inspections for new/existing product development
  • May conduct internal Quality system audits and be involved with CAPA projects.
  • May have involvement in training others on QA topics.
  • Responsible for authoring technical assessments as part of the Health Hazard Evaluation process
  • Responsible for participating in discussions with medical professionals for medical assessments as part of the Heath Hazard Evaluation process
  • Responsible for coordinating and presenting Heath Hazard Evaluations to the Risk Management Board, as appropriate
  • Responsible for participating in discussions with Corporate related to Health Hazard Evaluations, as appropriate
  • Responsible for participating in discussions with Regulatory Agencies related to Health Hazard Evaluations that result in potential Product Field Actions, as appropriate

Job Requirements

  • B.S. in engineering or engineering related discipline
  • 3+ years experience in an engineering/manufacturing environment or in quality engineering role in a regulated environment
  • Experience with medical device development and manufacturing
  • Experience in a Quality role familiar with FDA and ISO requirements.
  • Working knowledge of Risk Analysis, GD&T, SPC, Root Cause Analysis, Statistics and practical applications
  • Excellent analytical and problem solving skills
  • Excellent interpersonal skills
  • Excellent organizational skills
  • Process validation experience; preferred knowledge of GHTF approach to validation
  • Working knowledge of FDA, ISO, and other regulations and standards
  • ASQ Certifications (CQE, CRE, CQM, CSSBB)

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