About the Johnson & Johnson Medical Devices Companies
Johnson & Johnson is a company committed to doing good for the world. We blend Heart, Science and Ingenuity to profoundly change the trajectory of health for humanity.
Johnson & Johnson Vision is a leading global optical company that develops life changing techniques for all ages. We provide eye surgeons and their patients with a complete solution that includes a range of advanced products and services developed to help people of all ages with sight defects. We offer market leading technique for laser surgery, equipment for cataract operations and intraocular lenses. We also offer a program for education and support that help eye surgeons to master the full range of the technology.
Johnson & Johnson Vision in Uppsala produce the ophthalmic viscoelastic device Healon. We manufacture our products from scratch. A substance is produced from raw materials and is through different steps in production processed to finished products. The whole process takes several days and monitored closely. A variety of quality assurance measures are made continuously. It is important that the product is free from particles, fibers and odor. Improvements to the product and the process are made continuously to lift the organization to a more efficient level and to position ourselves in front of our competitors. At our site in Uppsala, there are many different tasks and employees with different experiences and skills. We are about 120 employees located in Uppsala and 8 400 employees worldwide within Johnson & Johnson Vision.
Staff Compliance Specialist
The Staff Compliance Specialist assigned site will be in Uppsala, Sweden. The JnJ RC Surgical Vision Team is a global team including sites from Anasco, Hangzhou, Groningen, Ireland and California and Florida.
Objectives of the Position
- Conduct internal and external QSR/GMP/ISO quality system audits and follow-up activities. (50%).
- Assist project teams with identification of quality system requirements to ensure compliance. (15%).
- Act as liaison with external auditors during third party/regulatory audits. (10%).
- Monitor regulatory agencies for changes in requirements and evaluates impact to the organization. (5%).
- Perform other related duties as assigned by management. (20%).
- Bachelor’s Degree - Scientific Discipline or equivalent.
- Minimum of 4 years of working experience in the quality assurance / compliance audit environment. Minimum of 3 years auditing experience.
- Strong communication, organizational, negotiation and interpersonal skills.
- Expert knowledge, understanding and application of audit principles, concepts and practices related to quality system regulated by domestic and foreign governments.
- Understanding and knowledge of a broad set of regulations and standards (e.g. 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; EU MDD/MDR; Australian Therapeutic Goods Regulations No. 236; Brazil GMP Regulations Resolution RDC n°16; CMDR – SOR98-282; Japan MHLW Ordinance No. 169; 21 CFR 50, 54, 56, 58; 21 CFR 812 and 814; ICH GCP Guidelines, MDSAP, etc.).
Preferred Skills & Experience
- Certified ISO/13845 Quality Assurance Auditor/Lead Auditor highly preferred
- Position location is Uppsala, Sweden and may require up to 10% travel.
AMO Uppsala AB (8507)