Quality Engineer Job

Quality Engineeris needed to perform the following duties:

· Works under a Team Lead but must be able to work independently as a high-level executor.

· Supports ongoing FDA remediation tasks ensuring documentation meets regulatory expectations.

· Develop clear, concise documentation outlining vendor expectations, requirements, and quality standards to ensure compliance.

· Will work on documentation related to FDA findings.

· Implement remediation processes for non-conformance and coordinate with cross-functional teams to resolve issues.

· Will review, assess, and update 2,300+ documents for compliance with internal and regulatory standards.

· Responsible for assessing Device Master Records (DMRs)—specifically manufacturing instructions for operators. Should have strong understanding of manufacturing SOPs and experience working in a remediation environment.

· Manage the budget for some of the products and services that would impact the final product directly

· Must have good interpersonal, communication (both written & verbal), ability to create detailed documentation, and problem solving skills. Implement the gap assessment of FDA. Identify gaps on the same and change and integrate processes to adhere and comply to FDA.

· Manage Quality Notifications in Windchill and ensuring timely completion and closing of the notifications as per procedures.

· Perform work with minimum supervision and have the ability to prioritize tasks.

Bachelor's Degree is required in Mechanical Engineering or Engineering Management or Engineering and Operations Management.

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave