Equipment Validation Engineer

Key Responsibilities:Support planning and execution of process verification and validation activitiesLead inspection planning activities to ensure all Critical to Quality (CtQ) features are verified with appropriate, qualified inspection and test methodsProvides support on activities, documents and records requiring Quality review and/or approvalConducts and/or participates in troubleshooting and/or deviation investigation efforts during project executionSupport Quality process knowledge transfer activitiesPartner with cross-functional partners to ensure completion of activities in alignment with project strategy and timelineBusiness Improvements: Conduct benchmarking to develop more effective methods for improving quality. Support quality improvement initiatives such as process and product characterizationsCompliance/Regulatory: Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.New Product/Process Introduction: Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges. Supports the development of quality strategies related to the transfer of products, materials and components. Supports new product introduction as part of design transfer.Risk Mitigation: Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard.Timely escalation of risks and emerging issues to project leadershipQualificationsEducation:A minimum of a Bachelor’s degree in a Technical of Scientific subject areaExperience and Skills:Required: A minimum of 4 years of experience in Supply Chain, Quality and/or R&D within a GMP or ISO regulated industryExcellent problem solving and decision-making skillsExperience conducting Process Verification / Validation including IQ / OQ / PQ, TMV and creation of other validation documents such as URSExperience leading risk management activities and developing associated documentation, such as Failure Modes & Effects AnalysisInterpersonal skills that foster collaboration as it relates to technical situationsStrong initiative and follow-through in completing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experiencePreferred:Other Advanced degree or a degree with a focus in Engineering, Science, Computer Science, or Digital areaQuality Engineering experienceExperience with CNC MachiningExperience with inspection & test methods including GD&TExperience working with MES systems and associated Quality process flowsStrong experience with Six Sigma or Lean