Supplier Quality Assurance Specialist

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 experience
• 2+ years of related experience preferred; candidates / incumbents should possess the following :
• Demonstrated technical competency and working technical knowledge and application of concepts, practices and procedures
• Ability or aptitude to work on problems of moderate scope
• Ability to form and develop interpersonal, professional relationships
• Display socially and professional appropriate behaviour
• FDA 820 and ISO 13485 familiarity
• Ability to work independently and in groups; ability to work cross-functionally
• Ability or aptitude to exercise judgment within defined procedures and practices to determine appropriate action
• Demonstrated initiative and problem-solving skills; critical thinking skills
• Ability and aptitude to use various types of databases and other computer software; ability to prioritize; strong organizational skills
• Ability to quickly gain knowledge, understanding or skills, and is willing to learn
• Excellent writing and communication skills

Please send all qualified CV's to [email protected]

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