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Supplier Quality Engineer

Uppsala, Johnson & Johnson, Medical Device, Quality, Suppliers

Hays is recruiting a Senior Supplier Engineer for our client Johnson & Johnson. This is a permanent position based at the Johnson & Johnson site in Uppsala.

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 produces 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.

Supplier Quality Engineer

The Supplier Quality Engineer is responsible for overall Quality Assurance and leadership in the management of quality impacting suppliers and purchasing control systems. This position will identify and eliminate supply chain risks, ensure suppliers are technically competent, lead supplier quality development, and ensure that suppliers’ and internal practices are executed in compliance with company requirements and applicable regulations. Key areas of focus are risk management, defect resolution, supplier process capability/improvement, supplier and QMS performance monitoring, and quality assurance general support. Additionally, this position will be responsible for supporting health authority inspections, completing department/franchise objectives as assigned while demonstrating Credo values and behaviours.

The Supplier Quality Engineer will be based in Uppsala, Sweden and will be part of a larger External Manufacturing & Supplier Quality global team including sites from Añasco, Hangzhou, Groningen, Ireland and California and Florida.

Objectives of the Position
  • • Lead activities associated with resolving supplier quality issues. This includes working with supplier and J&J Vision resources to perform root cause analysis/failure investigations, identifying and implementing corrective actions, and monitoring for effectiveness. (25%)
  • Lead activities associated with supplier risk management. This includes working with suppliers to identify areas of high risk within their processes; establishing, monitoring and implementing supplier risk mitigation plans; participating in supplier risk management projects; and ensuring management awareness of risks, gaining support for mitigation efforts and tracking progress. (25%)
  • Lead activities associated with supplier process improvement. This includes working with suppliers to identify sources of variation within their processes; implementing process controls to improve process capability; and driving implementation of best practices. (20%)
  • Perform and support supplier/EM quality evaluations and/or audits, development of quality agreements, and other quality related activities impacting supplier. (20%)
  • Develop and report on supplier performance metrics. Participate in local site supplier quality meetings to ensure communication and alignment of quality initiatives. (10%)

Qualifications required
  • A minimum of a Bachelor's degree is required, preferably in an Engineering, Life Science, or related discipline.
  • A minimum of 7+ years of experience in a highly regulated industry is required. Experience in the Medical Device or Pharmaceutical industry is preferred.
  • FDA and ISO regulations knowledge are required, with FDA CFR Part 820 and ISO 13485 knowledge preferred.
  • Strong communication, organizational, negotiation, interpersonal and problem-solving skills.
  • Position location is Uppsala, Sweden and may require up to 30% travel.

Preferred Skills and Experience:
  • Experience or knowledge with packaging, chemicals and plastics an asset.
  • Certified ISO/13845 Quality Assurance Auditor/Lead Auditor preferred.
  • Six Sigma, Lean or ASQ CQE Certification and trainings an asset.
  • Strong statistical skills preferred.

To apply and get additional information If interested in this position, please send in your application today. The selection process will start during the posting period. In case of questions, please reach out to the responsible Recruitment Consultant Helena Marteus or Moa Palm.

Sammanfattning

Jobbtyp:
Rekrytering
Industri
Sjukvård
Ort
Uppsala
Specialisering
Medicinteknik
Ref:
898121
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Tala med en konsult

Tala med Moa Palm, specialistkonsulten som hanterar denna position, i 114 35

Sturegallerian, Stureplan 4C, 114 35, Sweden, Stockholm

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