Validation Engineer

Location- Rochester, NY

Duration-12 + Months Contract position on W2

Qualifications:

• 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.

Responsibilities:

• 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.