- Employee will work with R&D personnel to facilitate material and supplier qualification for new product development projects and initiatives.
- They will ensure suppliers are aligned to meet quality standards and regulatory requirements and to facilitate timely resolution of quality, including the ongoing evaluation and performance monitoring of suppliers.
- Person will also work with production and compounding regarding component and/or raw material defects and communicate with the supplier.
- Conduct supplier evaluation and risk assessments including on-site quality audits to ensure conformance to Supplier Quality System requirements.
- Work to identify and resolve potential problems and continually improve the process for qualification and evaluation of new and existing suppliers, specifications, components, and materials.
- Analyze audit results to develop, prioritize and execute corrective actions and supplier development action plans to continually improve supplier performance.
- Ensure closure of Supplier NCRs and CAPAs, to confirm comprehension, development, and execution of corrective/preventive action regarding any cited nonconformity.
- Develop supplier scorecards and metrics to improve quality of the product and process with measurable KPIs
- Provide supplier quality support on NPD and incoming purchased finished goods initiatives.
- Act as the key interface with site operations as it pertains to Supplier Quality Issues.
- FDA, GMP, Supplier Quality, Quality Systems
- Bachelor Degree
- 3-5 years experience in a regulated environment
- 3 years experience in Quality
- 2 years experience in supplier interfacing role
- Knowledge of cGMP Guidelines and regulatory requirements.
- Strong time management/project management capabilities
- Working knowledge of Process / Manufacturing applications
- Ability to manage multiple projects simultaneously while meeting project milestones and timelines
- Click Apply and one of our team members will be in touch.
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Supplier Quality Engineer - Florida, United States - GradBay
Description
Our client is a global leader in engineering and sciences services and talent solutions.
Job Details:
This person will be responsible for the ongoing management of quality performance, and oversight of quality issue resolutions for Suppliers. Primary responsibilities include evaluating and qualifying current and new suppliers, contractors, and consultants based on their ability to meet specified requirements, including regulatory, quality, safety and security requirements.
Interaction with other functional areas:
Other Responsibilities:
Skills:
Additional Skills & Qualifications:
How to Apply: