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Quality Assurance Engineer (Expert Level)

Quality Assurance Engineer (Expert Level)

TalentBurst

Hebron, KY โ€ข On-site

Contractor

Medical, Dental, Vision, Retirement

Posted 3 days ago


Job description

Job Title: Quality Assurance Engineer (Expert Level)
Location: Hebron KY
Duration: 12 months

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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Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.


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About TalentBurst

Sourced by ZipRecruiter

TalentBurst is a leading provider of Information Technology and Engineering staffing solutions based in Natick, Massachusetts, US. An industry veteran with two decades of experience in their portfolio, the company's services range from IT consulting, life sciences, HR solutions, payroll services, and more. TalentBurst was founded with a mission to provide world-class, global staffing services to clients of all sizes. They strive to provide unmatched quality and service to their clients, which has earned them the reputation of being a highly respected and trusted staffing firm.

Industry

Recruiting and staffing services

Company size

51 - 200 Employees

Headquarters location

Natick, MA, US

Year founded

2002

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