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Engineering - Engineer - Quality Assurance (Expert Level)
Job Description
Shift: 1st Shift M-F
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).
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Staffing Leader of the Year Anju Abel
CEO, LanceSoft
LanceSoft is proud to announce that its Chief Executive Officer, Anju Abel, has been honored with the prestigious "Staffing Leader of the Year" award at the 2025 TIARA Staffing Awards US. The award recognizes her visionary leadership and significant contributions to improving staffing processes, employee engagement, and workforce outcomes.
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"This award is a testament to the incredible team at LanceSoft and our unwavering commitment to redefining staffing solutions," said Anju Abel. "I'm honored to receive this recognition and proud of the impact we continue to make in the lives of our clients and talent worldwide."
The judging panel highlighted Anju's ability to consistently deliver outstanding client success stories, exceed expectations, and foster professional development within her team. Her active community involvement and dedication to advancing the staffing industry were also key factors in her selection.
TIARA Awards are known for celebrating excellence, innovation, and achievement in the talent acquisition sector, and this accolade places Anju among the top leaders reshaping the future of workforce solutions.