Quality Assurance Specialist, Medical Devices & Compliance

Kelly Science, Engineering, Technology & Telecom; O’Fallon (MO); Sur place; USD 48 000 - 50 000; Plein temps

Résumé du poste

Kelly Sciences is seeking a Quality Assurance Specialist for a premier medical device organization in O'Fallon, MO. The role focuses on quality system activities, CAPA, audits, and documentation to ensure regulatory compliance.

The position offers pay at $35–$36 per hour, depending on experience, and a contract length through June 2027 with potential extension. A Bachelor’s degree in a scientific or technical field is required, with preferred experience in regulated environments.

Qualifications

• Bachelor’s degree in a scientific or technical field is required.
• Experience with quality systems in a regulated environment preferred (medical device/pharma).
• Proficient with electronic quality system software and Microsoft Office.
• Strong attention to detail, organized, and well-documented.
• Able to work in cross-functional teams and communicate clearly.

Responsabilités

• Administer and document quality system activities within electronic quality system software.
• Manage product complaint intake, evaluation records, and NCR documentation.
• Ensure calibration documentation, controlled document changes, and quality data metrics.
• Compile and report quality metrics including nonconformance metrics and QPIs.
• Assist with internal and external audit support, including record retrieval and document control.
• Prepare and manage Document Change Requests (DCRs) and CAPA documentation.
• Ensure all quality system records are accurate, timely, traceable and compliant.

Connaissances

Attention to detail

Documentation skills

Cross-functional collaboration

Formation

Bachelor's degree in a scientific or technical field

Outils

Quality management software

Microsoft Office

Description du poste

Kelly Sciences is seeking a Quality Assurance Specialist for a premier medical device organization in O'Fallon, MO. The role focuses on quality system activities, CAPA, audits, and documentation to ensure regulatory compliance.

The position offers pay at $35–$36 per hour, depending on experience, and a contract length through June 2027 with potential extension. A Bachelor’s degree in a scientific or technical field is required, with preferred experience in regulated environments.