Engineering - Sr Engr
Engineering - Sr Engr
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Job Description
Job Summary:
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 crossfunctional 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 qualitydriven culture.
Qualifications:
- Bachelors 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 problemsolving 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. To learn more about us please visit our website
Employment Type
Full Time
