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Validation Engineer
Ref No.: 18-10789
Location: Rochester, New York
Start Date / End Date: 09/10/2018 to 09/04/2020
• Works independently and sets an example in ensuring compliance to Design Controls and other Quality System requirements to assigned project(s). • Utilizes Six Sigma/Process Excellence to solve complex problems and develop optimal product performance. • Partners with R&D, Operations, Quality, Regulatory and Compliance, suppliers and other groups to ensure effective product development and transfer of knowledge. • Provides technical input as appropriate. • Ensures effective implementation of risk management requirements to prevent unanticipated failure modes and quality issues. • Provides input as needed to regulatory inspections. • Executes Failure Investigations and corrections of design related quality issues. • Utilizes advanced Quality Engineering tools (data analysis, statistics, sampling plans, etc.) to ensure effective product development. • Participates in post-product launch failure investigations. • Provides guidance and leadership to junior members of the team.. • Suppliers/External Manufacturers: Directly or indirectly support design change control activities. • Review and approve plans/protocols and reports, deviations/nonconformances, and document changes through the change control processes for accuracy and completeness. • Proactively identifies issues, troubleshoots issues, and escalates concerns as appropriate. Adheres to strict procedural and quality standards including thorough and accurate documentation, testing protocols.

Quals--
• A minimum of a BA/BS in Life Sciences, Engineering, Physical Science or a related discipline is required; an MA/MS in Life Sciences, Engineering, or Physical Science is preferred. • Must have at least 5 years of related experience in Medical Device quality system management, including experience in working under Design Control. • ASQ certification a plus. • Computer skills/data analysis skills (Word, Excel, PowerPoint, Minitab, Visio, MS Project) is required. • Effective oral & written communication skills are required.