Quality Specialist (Texas)

The Quality Specialist ensures Steri-Tek complies with all applicable regulatory standards including ISO 13485 and 11137, and that all Quality System Procedures are followed in an accurate manner. Assist the Quality Manager in any activities required to maintain the effectiveness of the Steri-Tek Quality System. Below are the primary responsibilities for this position. Additional responsibilities such as project management will be also assigned at the discretion of the Quality Manager and/or Assistant Quality Manager.

Core responsibility

• Review batch record documentation for accuracy and completeness during QA checks
• Good Documentation Practice (GDP)/ Good Manufacturing Practice (GMP) review to meet medical device industry standards
• Ensure that the Steri-Tek Quality Management System is compliant with appropriate industry standards (i.e. FDA 21 CFR Part 820; FDA 21 CFR Part 58; FDA 21 CFR Part 210/211; FDA 21 CFR Part 1271; ISO 13485; ISO 11137-1)
• Collaborate with customers when necessary to resolve discrepancies related to incoming products, audits, batch record documentation, and non-conformance resolutions
• Maintain and monitor the health of the Quality Management System (QMS) to ensure accuracy for SOPs, work instructions through reporting of Key Performance Indicators (KPIs)
• Responsible for implementing and maintaining the effectiveness of the QMS through document control

BATCH RECORD REVIEW

• Thoroughly assess documentation within batch records, validating information against established standards and specifications
• Responsible for coordinating documentation completion in a timely manner in accordance with business standards
• Inspect physical product against batch record documentation
• Identify and document non-conformances to specifications and/or processes, as needed
• Ensure that batch record review and release are completed within deadline

DOCUMENT CONTROL

• Initiate or review changes to controlled documents through change control, utilizing Steri-Tek eQMS
• Perform evaluation of change control for new or revised documents
• Collaborate with other departments (and customers as needed) to obtain approvals for change control documents
• Complete new documentation implementation and distribution through Steri-Tek eQMS
• Maintain all records associated with Document Control – both electronic and hard copy

QMS MAINTENANCE

• Collaborate with the Quality Manager in Training, CAPA, Non-Conformance, Complaint, Calibration, Preventive Maintenance and Audit programs
• Document and contribute to Nonconformance/CAPA processes and collaborating with other departments to determine/execute corrective actions
• Independently utilize quality management techniques to perform investigations and facilitate solutions
• Assist in the creation and maintenance of documentation, including SOPs, quality manuals, and validation protocols
• Collect, review, and create the necessary documentation required for QMS programs, including policies, procedures, and work instructions
• Management of the Approved Supplier Log (ASL) to assure that all material, service and component suppliers are properly assessed and re-evaluated in accordance with SOP requirements
• Schedule and perform routine equipment calibrations/preventive maintenance to ensure accuracy and precision
• Maintain a detailed record of calibration/preventive maintenance activities, including calibration dates, results, and any necessary adjustments
• Efficiently manage the due dates and implementation timelines for various QMS programs

Other duties as assigned by Quality Manager

Requirements

MINIMUM REQUIREMENTS/QUALIFICATIONS

• High School Diploma or equivalent experience
• Proficient in English language (written and spoken)
• Microsoft Office

PREFERRED QUALIFICATIONS

• Bachelor’s Degree or equivalent experience
• Medical Device industry experience – 1-3 years

Benefits

Steri-Tek offers medical, dental, vision, 401K with matching, and paid holiday and paid time off.

Work schedule: Day shift, working Monday - Friday, 10:00 AM - 7:00 PM. Note: training will be from 8:00 AM - 4:30 PM or 8:30 AM - 5:00 PM from Monday to Friday for about 4-8 weeks.