Senior Quality Engineer Service & Repair

The Senior Quality Engineer S&R serves as point of contact for quality and compliance aspects for World Wide DePuy Synthes Service Centers. Ensure general compliance support for correct execution of Quality System procedures at all DPS Service Sites. Responsible for harmonizing and monitoring processes related to specific aspects of quality systems such as training and quality agreements deployment. Lead service procedures harmonization at Depuy Synthes sites that execute service and repair of finished devices. Provides project leadership and analytical problem-solving expertise. You will be responsible for:

• Be the main point of contact for quality and compliance aspects for WW DPS Service Centers
• Ensure general compliance support for consistent and correct execution of QS procedures at all DPS Service Sites
• Ensure compliance of all DPS Service sites to global and regional regulations
• Collaborate with Service Operations to ensure global harmonization of service processes.
• Collaborate with Customer Quality representatives to ensure compliance with reporting
requirements of all DPS Sites and accuracy of service evaluations linked to customer complaints.
• Support tracking of monthly performance and quality metrics for each DPS site.
• Coordinate and support resolution for all nonconformances, CAPAs and audit observations related to Installation and Services.
• Support procedures update and harmonization for global service alignment for DPS sites.
• Ensure the quality and compliance of service processes and record for NCs, CAPAs, Product Quality Escalations and any data analysis supporting QPR and QSMR activities.
• 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 training 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.
• Lead continuous improvement activities to ensure efficiency, effectiveness, and compliance of DPS sites.
• Support training and alignment for changes related to service processes and system related issues.
• Support the deployment of KPIs and targets for projects deployed within Service.
• Conduct data driven analysis based on requirements.
• Lead a small off-shore specialist team.
• Available to travel to local DPS Service sites.
• Responsible for communicating business related issues or opportunities to the 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 all Federal, State, local and Company regulations, policies, and procedures.
• Can train and produce 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.
• Performs other duties assigned as needed.
  
  Master's degree in engineering or other technical field preferred.
• At least 5 years of experience in Quality (medical devices field is a nice-to-have).
• Recommended Lean six sigma Green/Black Belt, Project Management Certification or ASQ
certification (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 a 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, and Salesforce are beneficial for this role.
• Fluent in English. Additional language skills are beneficial for this role.
  
  At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity., For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong