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]
Let's chat!
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