Job Description Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
Other duties & responsibilities may be assigned.
Requirements Minimum 3 years of experience in related role in the regulated industry.
Vast expertise in Product transfer and Validation Area, reviewing validation documents (CSV, IQ, OQ, PQ and Software Validation).
Experience and expertise in test method Validation (MSA).
Statistical Knowledge and experience performing Attribute Agreement Analysis, DOE, Gage R&R, Ppk analysis, normality tests, tolerance interval for normal and non-normal data.
Experience generating Process maps, process flows and standard operating procedure changes.
Bachelor Degree in Engineering Completed.
Bilingual.
Willing to work 100% On-site.
Available to work weekends and other shifts when necessary.
Requirements Validation and Product Transfer Knowledge Statistical Analysis Knowledge Compliance and Technical writing knowledge