Associate Staff Quality Engineer- Supplier Quality - bioMérieux
Durham, NC
About the Job
Position Summary:
The Associate Staff Quality Engineer (QE) - Supplier Quality is responsible for the oversight of key tactical, functional, and operation aspects within Supplier Quality department at the Durham facility.
The Associate Staff responsibilities include, but are not limited to, providing quality oversite and guidance, identifying and resolving exceptions, participate on site CAPA teams, review and approval of procedures, protocols, and reports, identify gaps in existing Quality systems and propose recommendations to site management, perform trending, and perform Supplier audits.
Primary Duties:
- Supplier Audit program participation and qualify as an auditor.
- Perform Supplier qualification, routine, and “for cause” quality audits as needed by target timelines to assess the compliance to applicable regulations, standards and requirements. Follow up to ensure supplier responses to audit findings are acceptable.
- Administer the supplier change notification system. Perform and coordinate reviews to evaluate process impacts of vendor driven changes.
- Perform Quality Supplier Management activities including participation in the monitoring of supplier performance and provide nonconformance supplier quality metric inputs to the Supplier Steering Committee.
- Perform and investigate Supplier nonconformances and CAPA activities.
- Create, revise, and review SOPs including compliance documentation initiation, revisions, and deletions.
- Interface with Purchasing department in ensuring supplier quality system conformance. Interfaces with external organizations.
Education, Skills, & Experience:
- Bachelor’s Degree with minimum 5 years of experience in Quality, Engineering, or Technical Writing in a manufacturing/production environment
- Ability to effectively communicate verbally and in writing. Strong technical writing skills.
- Familiarity with relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.).
- Ability to work independently and in team environment.
- Competence in the selection and use of Quality Engineering Tools and Techniques.
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Source : bioMérieux