The Suppler Quality Assurance Specialist is responsible for supplier quality management including qualifying suppliers and monitoring supplier performance. Works independently and must be able to interact with suppliers in a tactful, professional and effective manner.
Main Responsibilities :
- Perform activities to qualify and risk assess new suppliers
- Monitor supplier performance, conduct desk top audits and support on-site supplier audits as required
- Work with suppliers as needed to ensure their performance is acceptable per site requirements
- Issue supplier corrective action reports (SCARs) as required and support the supplier’s investigation, CAPA planning and facilitate timely closure
- Review and approve verification and validation documentation for supplier processes
- Collaborate with Design and Development, Manufacturing, Purchasing, Engineering, Supply Chain, and IQC when qualifying and monitoring supplier performance
- Analyze supplier information and present supplier metrics
- Identify and implement with supervision, Supplier Quality Management process improvements
- Independently utilize quality management techniques to perform investigations and facilitate solutions
- Participate on cross-functional teams
- Understand and comply with applicable regulations, policies, procedures, and guidelines
Job Requirements :
Bachelor’s degree or equivalent in Life Science, Engineering, or closely related discipline; additional post-graduate education may contribute toward the desired years of experience2+ years of related experience preferred; candidates / incumbents should possess the following :Demonstrated technical competency and working technical knowledge and application of concepts, practices and proceduresAbility or aptitude to work on problems of moderate scopeAbility to form and develop interpersonal, professional relationshipsDisplay socially and professional appropriate behaviourFDA 820 and ISO 13485 familiarityAbility to work independently and in groups; ability to work cross-functionallyAbility or aptitude to exercise judgment within defined procedures and practices to determine appropriate actionDemonstrated initiative and problem-solving skills; critical thinking skillsAbility and aptitude to use various types of databases and other computer software; ability to prioritize; strong organizational skillsAbility to quickly gain knowledge, understanding or skills, and is willing to learnExcellent writing and communication skillsPlease send all qualified CV's to m.christin@maxsys.ca
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