Quality Engineer

Location: Rochester, New York Salary: US$50 - US$60 per hour + competitive
Sector: Pharma & Biotech, Medical Devices, Engineering, Engineering & Validation, Quality Assurance (QA), Quality Assurance (QA), R&D Type: Contract




I am partnering with a growing global Medical Device manufacturing organisation based in Rochester New York who are looking to secure a hands-on Quality Engineer on a 6-9 month contract.

It's imperative that the Quality Engineer has full product lifecycle experience in the Medical Device or Pharmaceutical industries and ideally some prior knowledge of plastic Injection moulding processes.

Key responsibilities:

  • Define, develop and implementation of the product quality assurance strategy, addressing all phases of product development, utilizing APQP (Advance Product Quality Planning) principles, including IQ/OQ/PQ validation process.
  • May direct quality department employees on processes for measuring, testing and tabulating data
  • Problem solving using CAPA system
  • Executing product testing efforts, including all associated resources to meet deadlines, in support of new product launch
  • Maintains product consistency through all phases of manufacturing, to include the design reviews, build phases and all quality checkpoints and testing
  • Support the daily function of the manufacturing operation
  • Develops and implements standards and methods for inspection, testing and evaluation of materials, products and processes.
  • Devises sampling procedures, designs and develops forms and instructions for recording, evaluating and reporting quality and reliability data
  • Implements programs to evaluate analytical testing, equipment, facilities, manufacturing processes, precision measurements, accuracy measurements and performance testing
  • Support cross functional teams on continuous improvement projects and new program launches to ensure manufacturing process and products are optimized and cost effective

Key experience required:

  • 3 years minimum experience in Quality Engineering function in Medical Device or Pharmaceutical manufacturing environment
  • Knowledge of Plastic Injection Moulding processes (preferred)
  • Proficient in process failure modes and effects analysis (PFMEA)
  • Experience in Design of Experiments (DOE)
  • Knowledge of Project Management concepts
  • Good communication skills and ability to interface with customers
  • Excellent analytical skills

This is an urgent requirement, so apply now if interested!

Sthree US is acting as an Employment Business in relation to this vacancy.