Website The Fountain Group LLC
The Fountain Group LLC
Company : The Fountain Group LLC
The Fountain Group is currently seeking a Quality Engineer for a prominent client of ours. This position is located in Austin, TX. Details for the position are as follows:
Pay: $40-$46/hr
7 month assignment (with potential to extend or convert based on performance and budget).
100% Onsite
Job Description:
- Lead the development and implementation of quality programs to ensure products and processes conform to product specifications and applicable regulations.
- Responsible for continuous improvement efforts with respect to Quality Controls to eliminate/reduce future recalls and ensure regulatory requirements and standards are met.
- Leads/Participates in CAPA and other non-conforming investigations. Identifies appropriate actions in response. Acts as investigation Subject Matter Expert (SME) for the site.
- Works directly with cross functional teams including Operations, Regulatory, Product Development, Supplier Quality, and PMO to ensure projects meet quality system requirements. Supports successful on time launches of new products and process transfers.
Qualifications:
- Bachelor’s Degree in Engineering discipline is required.
- 3+ years of quality engineering experience is required.
- Strong working knowledge in FDA and/or ISO regulations is highly preferred.
- Experience with sterile medical devices and clean room activities is desired but not required.
- American Society of Quality (ASQ) certifications, such as Certified Quality Engineer, preferred but not required.
- Top 3 skills: Quality Inspection Experience, Product lifecycle management system, and ERP systems experience (SAP is a plus).
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