Title :Validation Engineer
Location :Arlington TN (Onsite)
Duration: Contract
Visa Any valid visa except OPT/CPT/J1
Mazak I200 experience mandatory
Job Description:
- Background from Quality Mazaak i200 and EMC Oven Machine Validation
- Acts as a resource to work groups and project teams within the plant and outside the plant relative to quality and validation related activities.
- Need to have familiarity with manufacturing processes and products to evaluate the cause and effect of defects and identify trends in titanium machining process and product quality
- Provides technical input for projects using the application of FMEAs risk mitigation plant validations; DOEs and other experiments and investigations as assigned.
- Working knowledge of Validations IQ OQ PQ SIMS and DOEs is desirable.
- Should possess good knowledge in Machining process and its defect remediation activities.
- Should have good understanding and experience in GD&T and complex drawing interpretation.
- Should have hands on experience in creating PFMEA and Process control plans.
- Should operate autonomously to review vendor documents identify gaps and work with to close the gaps. Approve and assist in Launch of products.
- Coordinate with Vendor to complete the PPAP documentation.
- Should have sound experience in Non conformance identification RCA CAPA and implementation from medical device manufacturing background.
- Proven track record of supporting and driving continuous improvement activities in a production environment.
Qualification:
- Bachelors degree preferably Manufacturing Industrial Engineering
Skills:
- Bachelors degree in science engineering or manufacturing discipline
- Experience in ISO13485 certified and cGMP organizations preferred. Medical device manufacturing
- Background from Quality Mazaak i200 and EMC Oven Machine Validation