Quality Assurance Engineer

Lancesoft; Miami (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Lancesoft is seeking a Quality Assurance Engineer for its Process Validation group in the medical device sector in the United States. The role reports to the Senior Manager, Process Validation and collaborates with senior QA staff on process validation reagents within reagent manufacturing.

You will write and conduct IOQ and spreadsheet validations, complete PQ, TMV, and AQ validations, and help develop, maintain, monitor, and audit the quality management system and related protocols to ensure

Qualifications

• Bachelor's degree in engineering 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.

Responsibilities

• 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.

Education

Bachelor's degree in engineering (mechanical, electrical, chemical, bioengineering, or related)

Tools

Microsoft Excel

Programming knowledge

Job description

Duration: 0-12+ Months Shift: 1st Shift (Mon - Fri)

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).