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Quality Assurance Specialist

1 month ago

Oklahoma City, Oklahoma, United States Randstad Full time
Job Summary:

A Quality Engineer is needed for a medical technology company focused on the repair, regeneration, and replacement of soft and hard tissue. The Quality Engineer supports the company's Quality Management Systems by ensuring compliance with regulations, implementing continuous quality improvement programs, leading corrective actions, and maintaining quality reporting and regulatory compliance.

Responsibilities:

Support the Quality Management Systems to ensure compliance with regulations, standards, and guidelines, ensuring finished devices are safe, effective, and compliant with the Federal Food, Drug, and Cosmetic Act.

Vendor certification for ship-to-stock processes.

Design of experiments to identify and control process variables.

Quality systems improvement projects.

Internal and external QSRs (Quality System Regulations) and CAPA (Corrective and Preventive Actions).

Lead the review, disposition, and corrective action activities for discrepant components, materials, sub-assemblies, and finished products.

Incoming and in-process quality trends.

Returns analysis, categorization, and corrective action activities.

Qualifications:

Experience level: Experienced

Education: Bachelors

Skills: Quality, Compliance