GForce Life Sciences | Quality Engineer
GForce Life Sciences - franklin lakes, NJ
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Consultant, Quality Engineer, Medical DevicesSummaryOur client, a global medical device and diagnostic manufacturer, has engaged GForce Life Sciences to provide a Quality Engineer to for assure quality standards and regulatory compliance are consistent with Corporate and Division Policies, Government Regulations, International Standards and Standards of the Medical Device Industry. The Quality Engineer will be responsible for supporting new product development and product maintenance using electromechanical knowledge and Quality Engineering Skills.Job DutiesProvide Quality engineering support to all assigned projects, manufacturing facilities and suppliers.Function as a Quality Representative on DesignDevelopment and Manufacturing project teams.Assess current operations for quality and compliance.Develop & implement quality improvement programs.Ensure Design Control Elements are satisfied.Assistconduct Failure Investigations and problem-solving sessions.Support and lead batch release activities.Lead complaints investigation. Review and approve commercial products.Mandatory RequirementsBachelors degree in engineering or related field3-5 years of experience in quality engineeringGood understanding of Statistical Methods for Quality AssuranceGeneral working knowledge of the Six Sigma process methodologyExperience in Risk management (ISO14971)Thorough understanding of industry regulations: QSRcGMP, ISO QM standardsTerm & Start6 month contractHybrid in Franklin Lakes, NJ - 4 days onsiteBenefits available (Medical, Dental, Vision, 401k)
Created: 2025-01-06