Quality Assurance Supplier Engineer
2 weeks ago
The Fountain Group is currently in search of a Supplier Quality Engineer for a key client. Below are the details for this position:
Position Overview:
- Compensation: $40-$45/hour
- Duration: 3-month contract with the possibility of extension based on performance and budget considerations.
- Work Schedule: Monday to Friday, 8 AM – 5 PM.
- Key Responsibilities:
- Oversee the Supplier Quality Function, collaborating closely with Purchasing and the New Product Development and Engineering teams.
- Respond promptly and professionally to quality-related inquiries from both internal and external suppliers.
- Manage supplier modifications through the change management process.
- Evaluate Supplier Validation Protocols to ensure compliance with regulatory and customer standards.
- Coordinate with the engineering team to schedule and conduct first article inspections, capability studies, gage R&Rs, and more.
- Conduct thorough investigations and implement solutions for root cause analysis of product quality issues and defects related to both new and existing purchased products; assist colleagues with the Corrective Action process for purchased components and services as needed.
- Oversee the Supplier corrective action process and drive enhancements to the Approved Supplier List (ASL).
- Identify and execute continuous improvement initiatives to optimize quality systems and processes.
- Conduct external audits as necessary, based on the established audit schedule or when suppliers are not meeting quality metrics.
Qualifications:
- Bachelor's degree in Engineering, Manufacturing, Biology, or a related field, or an equivalent combination of education and experience is required.
- A minimum of 1 year of experience in Quality or Supplier Engineering is essential, preferably within the medical device sector.
- Proficiency in Microsoft Word, PowerPoint, and Excel is required.
- Familiarity with federal regulations and standards, such as QSRs, ISO 13485, CMDR, IVDD/IVDR, is preferred. A working knowledge of the General Provisions of 21 CFR Part 11 for Electronic Records and Electronic Signatures is also advantageous.
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