Sign upLog in

Quality Assurance Engineer (Expert Level)

TalentBurst, Inc.

Hebron, KY

Apply
JOB DETAILS
SKILLS
American Society for Quality (ASQ), Auditing, Automation, Bioengineering, Certified Quality Engineer (CQE), Code of Federal Regulations, Computer Programming, Electricity, ISO (International Organization for Standardization), Maintain Compliance, Manufacturing, Mechanical Engineering, Medical Equipment, Microsoft Excel, Process Validation, Quality Assurance, Quality Management, Quality Monitoring, Regulations, Regulatory Compliance, Spreadsheets
LOCATION
Hebron, KY
POSTED
30+ days ago
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).
#TB_OTH
#ZR

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.

About the Company

T

TalentBurst, Inc.

For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.

Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!

 

COMPANY SIZE
5,000 to 9,999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2002
WEBSITE
http://www.talentburst.com/

Resume Resources

Free Resume TemplatesFree Resume Builder