Equipment Validation Engineer

Key Responsibilities:
Support planning and execution of process verification and validation activities
Lead inspection planning activities to ensure all Critical to Quality (CtQ) features are verified with appropriate, qualified inspection and test methods
Provides support on activities, documents and records requiring Quality review and/or approval
Conducts and/or participates in troubleshooting and/or deviation investigation efforts during project execution
Support Quality process knowledge transfer activities
Partner with cross-functional partners to ensure completion of activities in alignment with project strategy and timeline
Business Improvements: Conduct benchmarking to develop more effective methods for improving quality. Support quality improvement initiatives such as process and product characterizations
Compliance/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 leadership

Qualifications
Education:
A minimum of a Bachelor’s degree in a Technical of Scientific subject area

Experience and Skills:
Required:
A minimum of 4 years of experience in Supply Chain, Quality and/or R&D within a GMP or ISO regulated industry
Excellent problem solving and decision-making skills
Experience conducting Process Verification / Validation including IQ / OQ / PQ, TMV and creation of other validation documents such as URS
Experience leading risk management activities and developing associated documentation, such as Failure Modes & Effects Analysis
Interpersonal skills that foster collaboration as it relates to technical situations
Strong initiative and follow-through in completing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience

Preferred:
Other Advanced degree or a degree with a focus in Engineering, Science, Computer Science, or Digital area
Quality Engineering experience
Experience with CNC Machining
Experience with inspection & test methods including GD&T
Experience working with MES systems and associated Quality process flows
Strong experience with Six Sigma or Lean
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