Johnson & Johnson
Quality Engineer
Job Title: Quality Engineer
Location: Oberdorf, Basel-Country, Switzerland (3 days onsite, 2 days home office)
Hours: 40
Duration:12 months (possible extension)
Essential: Experience within quality, manufacturing, medical devices
Languages: English (fluent) German (beneficial)
The role
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.
Key Responsibilities:
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
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
Ensure support in timely execution of NCs, CAPAs, Audit Observations, by cross-collaboration across functions, sites and evaluating issues for resolution
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 following all Company guidelines related to Health, Safety and Environmental practices as applicable.
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
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
Benefits
This role offers a competitive hourly rate & a supportive working environment.
About Johnson & Johnson
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.
https://www.jnj.com
application process
We are looking to process the first round of applications within the next 2 working days.
We do not accept applications via email. Please apply via the link.
Diversity, Equity & Inclusion
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 talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.