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Supplier Quality Engineer - Global Medical Company
- A car allowance or company car depending on the role and level
- Experience in the Advanced Wound medical field related to quality management
About Our Client
Our client is a global medical technology business dedicated to helping improve people's lives. We have almost 14,000 employees around the world and a presence in more than 90 countries. Our client has leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine, and Trauma Extremities and Fixation.
*Conducts and follows up on supplier quality system audits. Recommends changes in procedures, processes, design and/or equipment where necessary. Conduct Medical Supplier Audits for Film, Dressing and Unique Materials.
*Manage any technical/quality aspect related to suppliers Machining process and relevant evaluation of Advanced Wound products.
*Issue Supplier Corrective action requests, supplier performance reports and use other tools available to monitor and improve supplier quality. Initiate appropriate actions to establish an acceptable baseline for assigned suppliers.
*Use statistical techniques to perform complex data analysis from various data sources, identify the trend, and gap, drive supplier on continuous improvement.
*Establishes and maintains supplier quality risk management and mitigation approaches and schemes.
*Participate as a member on the new product development process (GS8 process), supplier first article readiness validation and IQ/OQ/PQ validation (training, coordination and verification).
*Develop and maintain thorough knowledge of technological developments and trends for guidance of commodity teams in advancements of design, quality, and manufacturing
*Maintain supplier files and electronic databases as assigned.
*Work with suppliers to assure proper process control standards are in place and continuously monitor key manufacturing processes for improvement opportunities
The Successful Applicant
*University or equivalent education background, major in chemical or Pharmaceutical with at least 4 years' experience in the Advanced Wound medical field related to quality management, internal/external auditing or relevant work experience.
*Working knowledge of QMS Standards required (FDA, ISO13485, etc)
*Working knowledge of medical device manufacturing system requirements (GMP, 21 CFR 820).
*Experience in performing supplier audits and assessing supplier capabilities. Certified ISO 13485 Quality Auditor preferred.
*Good knowledge of manufacturing processes is needed as well as a strong technical background of chemical, packaging technologies.
*Experience in performing IQ/OQ/PQ. (sterilization, sealing, cleanroom).
*Hands-on experience in the application of root-cause and problem solving techniques involving supplier-based processes (5 why, 8D report)
*Ability to perform complex analysis based on data driven variables and make independent decisions with regard to supplier quality systems. Good knowledge of Quality tools SPC, PCS, PFEMA, Control Plan, MSA, etc.
*Six Sigma Green or Black Belt preferred.
*Successful track-record of serving as a change agent both internally and externally to the organization
*Must be an independent worker capable of performing to high levels with minimum level of oversight
*Good written and oral communication in English.
What's on Offer
*A competitive basic salary with an annual incentive bonus scheme
*A competitive company pension/retirement benefit scheme for all employees
*Healthcare coverage at most levels
*A car allowance or company car depending on the role and level
*International working environment