Cardinal Health · 3 days ago

Senior Quality Engineer

Riverview, FL

Full-time

Onsite

Mid Level

$66K/yr - $95K/yr

2+ years exp

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Responsibilities

Performing and documenting root cause investigations related to raw material, product, and component rejections.

Writing protocols and performing validations of new/improved materials and processes.

Responsible for assisting QA Manager in designing, building, and managing the facility Quality System to achieve compliance with regulations.

Generating and maintaining Quality System documentation.

Ensures products manufactured or processed in the Tampa facility are safe and effective.

Ensuring FDA/ISO compliance in areas of responsibility.

Manage non-critical projects with input from QA Manager.

Presenting quality data to Management.

Supporting Production personnel by resolving process and material-related quality problems in support of the various manufacturing departments.

Supporting plant cost reduction and process improvement projects through the use of various Quality tools such as FMEA, process capability, Gage R&R, pareto analysis, etc.

Performing regular internal audits of the Quality System.

Performing Quality Systems audits of suppliers.

Revising documents using the AGILE documentation system.

Lead and support change control via the AGILE Change Request System (CDP).

Qualification

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Six Sigma LeanASQ Certified Quality TechnicianASQ Certified Quality Auditor