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Medical Device Quality Engineer
Ref No.: 18-42471
Location: Rochester, New York
Position Type:Contract
Job Category:Biotech/Pharmaceutical
Benefits:401K, Dental Insurance, Medical Insurance
*2 year contract position with possibility of hire*

The company: Our client is an in vitro diagnostics company that makes products and diagnostic equipment for blood testing. 

• 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.
•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. 

Pay Rate: $44 - $48 per hour  based upon qualifications
Drug and background screenings required

On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.