Job Description:
The Quality Assurance Engineer is part of the Process Validation Group, specializing in all types of validation deliverables.
The Quality Assurance engineer is a key member of the PV team, reporting to the Senior Manager, Process Validation. You will collaborate with senior QA staff, taking responsibility for Process Validation Reagents within Reagent manufacturing.
In this role, you will have the opportunity to:
Write and conduct IOQ and spreadsheet validations.
Complete PQ, TMV, AQ validations.
Develop, maintain, monitor, and audit quality management system and protocols, including systems automation, processes, and procedures that ensure compliance with regulations and standards.
The essential requirements of the job include:
Bachelor's degree in engineering (mechanical, electrical, chemical, bioengineering, or a related area) and 5+ years of experience in the medical device industry.
Familiarity with CFR 21 Part 820 and ISO13485.
Proficiency in Microsoft Excel and a good working knowledge of computer programming and systems.
It would be a plus if you also possess previous experience in:
Knowledge of PQ, TMV, AQ, NPSV validations.
Exposure to Gamp5 or similar regulations.
ASQ Certified Quality Engineer (CQE).