Sr. Quality Engineer

1 week ago

Grand Rapids, United States Redbock - an NES Fircroft company Full time

Sr. Quality Engineer (12 month contract // Grand Rapids, MI):


W2 Candidates only. No third party candidates will be considered.


Top Required Skills:

  1. Experience with Production Quality (CAPA/NCR) and Operational Excellence (Process Characterization and Improvement, Lean/Six Sigma methodologies, and First Time Quality)
  2. Experience with Capital Expansion/Projects (Process/Equipment Validation and IQ/OQ/PQ)
  3. Experience with Test Method Development and Validation (Nested vs Crossed, Attribute vs Variable, Design of Experiments)
  4. Experience with leading and driving small to large projects for capital expediture


Education: Bachelors Degree Required

Experience: 4-6+ years of Medical Device Mftg experience


Duties:

  • Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
  • Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
  • Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
  • Adapts machine or equipment design to factory and production conditions.
  • May incorporate inspection and test requirements into the production plan.
  • Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
  • Develops manufacturing processes that are applicable to statistical process control and may be asked to develop those techniques.
  • Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
  • Ensures processes and procedures are in compliance with regulations.


Required Knowledge and Experience:

  • Bachelor’s Degree in Engineering, Science, or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science, or technical field with 2+ years of work experience in Engineering and/or Quality

Preferred Skills:

  • ASQ certification in Quality Engineering
  • Experience with polymer-based products, including extrusion and injection molding ideally
  • Familiarity with packaging and sterilization equipment and processes for sterile barrier packaging, including Tyvex and other sealed trays and pouches
  • Proven leadership for process and system improvement
  • Experience and working knowledge of FDA regulations/ISO standards for medical devices
  • Strong interpersonal, organizational and project management skills
  • Demonstrated skills in complex decision-making
  • Demonstrated ability in coaching/developing team members
  • Demonstrated communication skills, both verbal and written
  • Strong interpersonal communication and influence skill
  • Ability to work in a team-based environment
  • Very strong in quality and compliance

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