Quality Assurance Engineer -- SARDC5798951

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