- US$50 - US$60 per hour + competitive
- Rochester, New York
- Pharma & Biotech, Medical Devices, Engineering, Engineering & Validation, Quality Assurance (QA), Quality Assurance (QA), R&D
6-9 MONTH 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.
- 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.