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Quality Assurance Engineer

1 month ago

Pittsburgh, Pennsylvania, United States Randstad Full time
Job Summary:

As a Quality Assurance Engineer, you will be responsible for facilitating product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring. You will project manage all aspects of CAPA activity, including gaining the commitment of cross-functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.

Key Responsibilities:

- Independently produce and complete CAPA records
- Perform timely, detailed CAPA engineering tasks, such as assessing issue descriptions, reviewing CAPA data sources, and assisting with root cause analysis and quality problem solving

Requirements:

- Bachelor's degree in an engineering or scientific related field or equivalent demonstrated strong technical competence
- Working knowledge of appropriate global regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO 9001, and ISO 14971
- 3+ years of related experience in medical device or other regulated industry

What We Offer:

- Competitive salary: $55 - 60 per hour
- Comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility)

About Us:

Randstad Digital is an equal opportunity employer and welcomes people of all abilities. We are committed to providing a fair and inclusive hiring and interview process for all applicants.