Quality Validation Engineer

4 weeks ago

Franklin, United States Actalent Full time
Job Title: Quality Validation Engineer

Job Description

As a Quality Validation Engineer, you will play a pivotal role in ensuring our production processes meet the highest standards of quality and efficiency. Your primary responsibility will be to analyze and validate production processes, assess their measurement capabilities, determine process capability, and implement improvements to meet customer requirements. As a team leader, you will manage and coach direct reports, guiding them in their daily tasks and professional development. You will serve as the site's subject matter expert (SME) for validation within manufacturing processes and oversee all new customer projects. Your expertise will be crucial in developing quality improvements, implementing cost-reduction strategies, and creating new analytical test methods. This position requires a strong analytical mindset, leadership skills, and the ability to drive continuous improvement in a dynamic manufacturing environment.
•Ensure product and process validations are completed.
•Perform discrepant material disposition with guidance.
•Recommend inspection plans, test methods, and standard operating procedures.
•Conduct sample size determination, statistical analysis, root cause analysis, and applicable training.
•Actively contribute to various manufacturing projects such as process development, cost reduction, and quality improvement initiatives.
•Collect and trend quality indicators for monthly and quarterly reviews.
•Support documentation development including writing specifications for manufacturing or scientific test results.
•Support in management, implementation, and documentation of IQ, OQ, PQ.
•Participate in cross-functional teams in continuous quality improvement projects.
•Participate in the Internal Audit process and assist in addressing observations.
•Determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
Hard Skills
  • Bachelor's degree in biomedical, chemical, or mechanical engineering
  • 5-7 years of quality engineering experience (PFMEA, Root cause analysis, scrap reduction, 5-whys)
  • Manufacturing Validation experience (IQ, OQ, PQ)
  • Medical Device experience
Soft Skills
  • Strong analytical mindset
  • Leadership skills
  • Ability to drive continuous improvement
  • Team management and coaching
Work Environment

Onsite Monday - Friday: 8am-5pm
About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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