Quality Assurance Specialist
10 hours ago
The Supplier Quality Assurance Specialist plays a critical role in ensuring the quality of products and services from our suppliers. This position is responsible for qualifying and monitoring suppliers, conducting audits, and implementing process improvements to maintain compliance with regulatory requirements.
Main Responsibilities:- Qualify and risk assess new suppliers to ensure they meet our quality standards
- Monitor supplier performance, conduct desktop audits, and support on-site audits as needed
- Work with suppliers to resolve quality issues and ensure their performance meets our requirements
- Issue supplier corrective action reports (SCARs) and support the supplier's investigation and corrective action planning
- Review and approve verification and validation documentation for supplier processes
- Collaborate with cross-functional teams to ensure supplier quality management processes are effective
- Analyze supplier information and present supplier metrics to stakeholders
- Identify and implement process improvements to enhance supplier quality management
- Bachelor's degree or equivalent in Life Science, Engineering, or a related field
- 2+ years of related experience, with a strong understanding of quality management principles and regulatory requirements
- Excellent communication and interpersonal skills, with the ability to work independently and in teams
- Ability to analyze data and present findings to stakeholders
- Familiarity with FDA 820 and ISO 13485 regulations
Please submit your resume to be considered for this exciting opportunity.
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