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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. Building on the legacy and strengths of two great companies, we are crafting one organization that will be agile and better equipped in today’s evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and well-being of people around the world.
DePuy Synthes a member of the Johnson & Johnson Family of Companies, is hiring a Global Service Technical Lead in Oberdorf, BL.
You would be responsible for WW projects for the implementation and management of calibration and validation activities in compliance to FDA regulations and ISO as required. You will support harmonization of calibration and validation 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 and support technical topics related to service evaluation for WW Service Centers including technical process issues and system relates issues.
- 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.)
- Coordinate 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 PTs 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 partners to investigate and document deviations identified
- Assist in determination of needs for validation/calibration and when appropriate generate rationales for " no calibration/validation required"
- 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 Service Centers
- Support training and alignment for changes related to technical processes and system updates
- Support the deployment of KPIs and targets for technical processes such as calibration and validation
- Conduct data driven analysis based on requirements
Does the description above match your profile? This is what we are looking for:
- Master Degree in Engineering or other technical field preferred
- 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
- Proven understanding of projects planning
- Excellent communications and analytical skills are required. — Ability to work in team is required
- Interpersonal skills, ability to resolve conflicts
- Analytical thinking
- High sense of responsibility and reliability
- Work Independently within established timelines
- English proficiency is required
- German knowledge or additional language skills are beneficial
- Lean six sigma Green/ Black- Belt or ASQ certification (CCT, CQE) are an asset for this position
- Experience with EtQ, Trackwise, Salesforce
- Available to travel at local PTS Service sites
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Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Synthes GmbH (7111)