Johnson & Johnson Careers
Requisition ID: 1905727176W
Caring for the world… one 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.
For our Regulatory Compliance Organization looking for a highly committed:
Compliance Specialist based in Balsthal/ Hägendorf (Permanent)
The Compliance Specialist ensures effective business wide compliance program that meets requirements for the medical device business. This position will partner with Compliance leaders globally to ensure audit readiness and overall compliance through internal audit process. This individual will collaborate with all levels building partnerships to further DePuy Synthes in the refinement of short- and long-term compliance objectives. This role provides Quality System Compliance support to the assigned site(s).
This includes the procedures and records required for the development, deployment and maintenance of quality system processes in order to assure the ongoing compliance with ISO13485, FDA QSRs and the Medical Devices Directive and other applicable regulations and standards.
- Responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures.
- Conduct and lead Internal Audit as per site Internal Audit schedule.
- Drive Compliance improvements, which result from audits, Quality Board Issues and other system indicators.
- Work effectively with the other site compliance specialist to ensure consistent systems across the organization.
- As JnJ Regulatory & Compliance representative and in high collaboration with site management, coordinate on a continuous basis, inspection Readiness tool in order to prepare the site for external audit announced or unannounced.
- Support creation, deployment and Maintenance of the internal audit schedule.
- Ensure proper internal audit reporting, response review and approvals, communication of issues, and use of tracking and trending tools.
- Train and maintain users on the Audit system “EtQ” - Act as site system Audit module support.
- Provide Front Room/ Back Room support during external audits.
- Establish and maintain regulatory inspection readiness plans for assigned sites.
- Support external audits and assessments that take place on DePuy Synthes sites and serve as the representative for the Internal Audit program.
- When required assist other facilities for both external audit preparation and assistance during their external audit.
- At least Bachelor’s degree in science, Engineering, Quality or another technical field.
- Extensive knowledge of Quality Systems (21 CFR 820/ISO 13485) within a regulated environment.
- At least 5 years working experience in a regulated industry.
- Experience in a quality and/or compliance function as well as leading performing audits is required.
- High attention to detail and the ability to make complex issues simple.
- Excellent Communication Skills (written & oral) in English and German.
- Excellent Team Player.
- Focus on achievement and delivery of results.
- High Sense of Urgency.
- Available to travel (mostly within Switzerland).
Synthes GmbH (7111)