Global Service Technical Lead
vor 3 Wochen
**_Caring for the worldone person at a time” _**inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.
**DePuy Synthes **Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings, help advance the health and wellbeing of people around the world.
We are looking for a highly committed:
Global Service Technical Lead based in EMEA
**(Permanent)**
**Overview**
Responsible for WW projects for the implementation and management of calibration and validation activities in compliance to FDA regulations and ISO as required.
Support harmonization of calibration, validation and onboarding/decommissioning programs, to ensure adequacy and consistency in terms of regulatory compliance and technical soundness. This should be accomplished by working closely with WW Service Center Managers, Manufacturing Engineering, quality engineering groups and business quality groups at each site.
Review/audit the validation and calibration system at all sites to ensure adequacy of current processes in place. Support update and harmonization of Global validation and calibration procedures for service Support technical related topics related to service evaluation for WW Service Centers including technical process issues and system relates issues.
**Further responsibilities and duties are**
- CAPA, NCs, Audit Observation management. Coordinate and support resolution for all nonconformances, CAPAs and audit observations related to technical service (e.g. validation, calibration, devices service evaluation etc.).
- Oversee calibration/validation activities at all sites to ensure adequacy and consistency of processes in place and compliance to FDA and ISO standards.
- Support Procedures updates and harmonization for global calibration and validation for WW DPSs sites.
- Creation of qualification/validations documents required in conjunction with local service sites, IT, Quality Engineering, Business Quality.
- Support Sites training related to procedural changes and coordinate with relevant stakeholders to investigate and document deviations identified.
- Assist in determination of needs for validation/calibration and when appropriate generate rationale for " no calibration/validation required" rationales.
- Support Onboarding/decommissioning tasks for new Service center or new product serviceability introduction in the Service Centre.
- Lead continuous improvement activities for calibration and validation programs to ensure efficiency, effectiveness, and compliance.
- Be main point of contact for all technical related topics related to service evaluation for WW DPS Service Centers.
- Support training and alignment for changes related to technical processes and system relates issues.
- Support the deployment of KPIs and targets for technical processes such as calibration and validation.
- Conduct data driven analysis based on requirements.
- Available to travel at local DPS Service sites.
- Planning, coordination and execution of activities in cross-sites projects for DPS service.
**Qualifications**:
**Education Requirements**:
- Master’s degree in engineering or other technical field preferred
**Further Education **(if applicable):
- Lean six sigma Green/ Black
- Belt or ASQ certification (CCT, CQE) are an asset for this position
**Experience**:
- Experience in Medical devices industry or highly regulated industry preferred
- Experience in Technical Services or Quality
- Consolidated knowledge on process validation for medical devices
- Consolidated knowledge on calibration requirements for medical devices
- International working experience
- Experience in deployment of calibration/validation process and related documentation
- Solid understanding of projects planning
**Interpersonal skills/ characteristics **(if applicable):
- Excellent communications and analytical skills are an Ability to work in team is required
- Organizational skills, ability to resolve conflicts
- Analytical thinking
- High sense of responsibility and reliability
- Work Independently within established timelines
**Other Requirements **(if applicable)**:
- Experience with EtQ, Trackwise, Salesforce
Additional language skills are beneficial for this role
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talen
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