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Job Function:
Quality Job Sub Function:
Quality Assurance Job Category:
Professional All Job Posting Locations:
IE002 Loughbeg, US014 MA Raynham - 325 Paramount Dr, US161 IN Warsaw - 700
Orthopaedic Dr Job Description:
DePuy Synthes, a member of the Johnson & Johnson Family of Companies, is currently hiring for a Quality Engineering Leader
The role can be located in: Raynham, MA / Cork, Ireland / Warsaw, IN.
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century.
With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide.
Together, we are working to shape the future of health through differentiated products and services.
The Quality Engineering Leader will be a critical member of the Supply Chain Quality organization supporting the construction and qualification of a new DePuy Synthes manufacturing facility at the future J&J MedTech campus in Alajuela, Costa Rica.
This individual will support management and definition of key Quality activities for successful project completion including validation plans, inspection plans, equipment qualification and business system design & deployment.
Does this sound like you?
Come join our Supply Chain Quality team today
Key Responsibilities:
The Quality Engineering Leader will lead a team of Quality Engineers and/or Technicians with the following responsibilities: Metrology: * Lead inspection planning activities to ensure all Critical to Quality (CtQ) features are verified with appropriate, qualified inspection and test methods.
* Review/analyze the effectiveness of current metrology equipment / techniques.
* Conduct technical benchmarking of new technology to develop more effective methods for improving quality impacted by metrology.
* Develop, interpret and implement appropriate process inspection and control methods consistent with the level of process/product risk
* Supports cross-site technical development of metrology engineering, quality compliance, quality leadership talents with the right skills for new product introductions, and product life cycle management.
* Support Quality process knowledge transfer activities.
Equipment Qualification * Support planning & execution of equipment qualification activities * Conduct and/or participate in troubleshooting and/or deviation investigation efforts during project execution * Assess 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.
Business Systems Design, Development & Deployment * Develop, test and deploy target state process map for Quality business processes across business systems (SAP S/4HANA, NextGen MSP, LabVantage LIMS).
* Define capability gaps in global templates, assist in analyzing solutions, and identifying possible workarounds.
* Define, populate and test all requisite master data (i.e.
Business Data Readiness).
* Develop procedures and deliver training.
People * Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for others as assigned (including Quality Engineers and Technicians).
* Partner across functions to ensure completion of activities in alignment with project strategy and timeline.
* Timely escalation of risks and emerging issues to project leadership.
Qualifications Education:
* A minimum of a Bachelor's degree in Engineering or other Technical or Scientific subject area.
Experience and Skills:
Required: * A minimum of 8 years' experience in Supply Chain, Quality and/or R&D within a GMP or ISO regulated industry * A minimum of 3 years of quality experience * At least 2 years of people leadership experience.
* Knowledge of the QSR and ISO quality requirements
* Excellent problem solving and decision-making skills
* Experience conducting Process Verification / Validation
* Experience leading risk management activities and developing associated documentation, such as Failure Modes & Effects Analysis
* Experience with inspection & test methods
* 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 in Engineering, Science, Computer Science, or Digital area
* Experience working with ERP and/or MES systems and associated Quality process flows
* Strong experience with Six Sigma or
Lean Other:
* This position may require up to 25% domestic & international travel