Validation Engineer

Posted 9y ago

Location- Rochester, NY

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.

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..

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.

Skills