Staff S&r Quality Engineer , Location: O

Point of contact for quality and compliance aspects for Service Centers. Ensure general compliance support for correct execution of QS procedures at DPS Service Sites.

Locally responsible for the transformation initiatives and transfer projects.

Responsible for harmonizing and monitoring processes related to specific aspects of quality systems such as training and quality agreements deployment.

Support service procedures harmonization at Depuy Synthes sites that execute service and repair of finished devices.

Provides project leadership and analytical problem-solving expertise.

In accordance with all applicable federal, state and local laws / regulations and Corporate Johnson & Johnson, procedures and guidelines, this position :

• Be the main point of contact for quality and compliance aspects for WW Service Centers with regards to cost-improvement initiatives and transfer projects
• Ensure general compliance support for consistent and correct execution of QS procedures at DPS Service Sites
• Ensure compliance of DPS Service sites to global and regional regulations
• Be the local main point of contact for quality and compliance aspects related to transformation initiatives and transfer projects
• Collaborate with Service Operations and other Supply Chain representatives to ensure global harmonization of service processes
• Partner closely with stakeholders and other project team members to ensure that any new initiatives at local Service Center are implemented and executed as per local and global quality requirements
• Collaborate with Customer Quality representatives to ensure compliance to reporting requirements of DPS Sites and accuracy of service evaluations linked to customer complaints
• Support tracking of monthly performance and quality metrics for each DPSs site
• Coordinate and support resolution for all nonconformances, CAPAs and audit observations related to Installation and Services
• Support Procedures updates and harmonization for global service alignment for DPS sites
• Ensure support in timely execution of NCs, CAPAs, Audit Observations, by cross-collaboration across functions, sites and evaluating issues for resolution
• Support Service Sites internal and external audits based on sites requirements
• Conduct trainings related to procedural changes and coordinate with relevant stakeholders to investigate and document deviations identified at the sites
• Maintain awareness of FDA and ISO regulations while developing solutions to satisfy business needs
• Support continuous improvement activities to ensure efficiency, effectiveness and compliance of PTS sites
• Support training and alignment for changes related to service processes and system relates issues
• Support the deployment of KPIs and targets for projects deployed within Service during project implementation and post-delivery phases.
• Conduct data driven analysis based on requirements
• Potentially lead a small team of 2 regional quality coordinators (only based on business needs and team size)
• Available to travel at local DPS Service sites
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and company compliance with company regulations, policies, and procedures
• Performs other duties assigned as needed
• Can train other engineers to SME status
• 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 such as the QSRs

Qualifications

• Master Degree in Engineering or other technical field preferred
• Experience in Medical Device environment (4-6 years)
• Preferred previous experience in Quality, Manufacturing or Service and Repair (3-5 years)
• Recommended Lean six sigma Green / Black Belt, Project Management Certification or ASQ certitification (CIA, CQE) are an asset for this position
• Experience in regulated ISO 13485 industries
• Excellent communications and analytical skills are required.
• Ability to work in team is required
• Organizational skills, ability to resolve conflicts
• Analytical / Problem solving skills
• High sense of responsibility and reliability
• Work Independently within established timelines
• Experience with EtQ, Trackwise, Salesforce, PLM and ERP systems are beneficial for this role
• Additional language skills (preferably German) are beneficial for this role
Vor 20 Stunden