Quality Engineer Contract Irvine Ca Onsite
The Quality Engineer is responsible for ensuring that products meet the highest quality standards and comply with regulatory requirements. This role involves developing, implementing, and monitoring quality systems, while collaborating with cross-functional teams to address quality concerns and ensure processes meet regulatory standards.
Key Responsibilities:
- Develop, implement, and maintain quality systems, processes, and procedures in compliance with industry standards and regulatory requirements (ISO 13485, FDA).
- Conduct Root Cause Analysis (RCA) and implement Corrective and Preventive Actions (CAPA) to address product and process quality issues.
- Perform product testing, inspections, and audits to ensure compliance with established quality standards.
- Analyze quality data to identify trends, risks, and areas for improvement, generating actionable reports.
- Collaborate with R&D, manufacturing, and supply chain teams to ensure products are designed, produced, and delivered according to quality specifications.
- Support the validation and verification of new products and processes, and manage nonconformance reports (NCRs).
- Train employees on quality processes and standards, fostering a quality-driven culture.
Qualifications:
- Bachelor's degree in Engineering.
- 5+ years of experience in quality engineering, preferably in regulated industries.
- Expertise in quality systems, including ISO 13485, FDA regulations, and GMP.
- Strong problem-solving, statistical analysis, and risk management skills.
- Proficiency with EQMS, Ignite, and JDE software preferred.
- Strong communication and teamwork skills, with the ability to work independently.
Trinus Corporation, a leading provider of technology solutions and services with over 25 years of experience, is a certified WBE/MBE/SBE/SDB firm accredited by WBENC, NMSDC, and SBA.
Our mission is to shape the future of work by aligning the right mix of people, process, technology, and innovation to efficiently meet our clients' business objectives.
At Trinus, we understand that finding the right opportunity is pivotal in your career journey. Our staffing services go beyond mere placements; they are about matching your skills and aspirations with the perfect fit.
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