Quality Assurance Engineer -- SARDC5798951

Quality Assurance Engineer -- SARDC5798951 at Compunnel Inc. Quality Assurance Engineer -- SARDC5798951 at Compunnel Inc. in Erlanger, Kentucky Posted in about 22 hours ago.

Type:

full-time

Job Description:

Job Description:

Part of the Process Validation Group, focusing on validation deliverables within reagent manufacturing Collaborate with senior QA staff and report to Senior Manager, Process Validation Responsible for Process Validation Reagents and related quality activities Write and execute IOQ (Installation & Operational Qualification) and spreadsheet validations Perform PQ (Performance Qualification), TMV (Test Method Validation), and AQ (Analytical Qualification) validations Develop, maintain, monitor, and audit Quality Management Systems (QMS) and protocols Ensure compliance with regulatory standards, systems automation, and process procedures Support continuous improvement of validation processes and documentation

Requirements:

Bachelor's degree in engineering (Mechanical, Electrical, Chemical, Bioengineering, or related field) 5+ years of experience in the medical device industry Familiarity with CFR 21 Part 820 and

ISO 13485

regulations Strong proficiency in Microsoft Excel and working knowledge of computer programming/systems

Preferred Qualifications:

Experience with PQ, TMV, AQ, and NPSV validations Exposure to GAMP5 or similar regulatory frameworks ASQ Certified Quality Engineer (CQE) certification