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Posted: Wednesday, March 8, 2017 7:46 AM

Job Description:/h3:
We are seeking a Validation Engineer who works independently and sets an example in ensuring compliance with 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 and 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 to 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.
: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 and written communication skills are requiredpany Description:/h3:
ATS is an information technologies consulting company providing services to Fortune 500 companies nationwide. ATS specializes in providing full:service staffing solutions by providing technical and business personnel through staff supplementation and project engagements. The company has extensive contacts within its Fortune 500 client base and is able to access a large pool of talented and responsive professionals with proven records of accomplishment in both the technical and business fields.

ATS offers health coverage, 401K participation, Long Term Disability and Life Insurance.


• Location: Rochester

• Post ID: 23946198 rochester is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2017