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Quality Assurance Validation Specialist

2 months ago

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

Job Overview

As a Quality Validation Engineer, you will be instrumental in guaranteeing that our manufacturing processes adhere to the utmost standards of quality and operational efficiency. Your key duties will include analyzing and validating production methodologies, evaluating their measurement capabilities, determining process capabilities, and implementing enhancements to fulfill customer expectations. In your role as a team leader, you will oversee and mentor direct reports, guiding them in their daily responsibilities and professional growth. You will act as the site’s subject matter expert (SME) for validation within manufacturing processes and manage all new client projects. Your expertise will be vital in fostering quality enhancements, executing cost-reduction initiatives, and developing innovative analytical testing methods. This position demands a robust analytical mindset, strong leadership abilities, and the capacity to drive continuous improvement in a fast-paced manufacturing setting.

• Ensure that product and process validations are executed effectively.

• Conduct material disposition for discrepancies with appropriate guidance.

• Propose inspection strategies, testing methodologies, and standard operating procedures.

• Perform sample size determination, statistical evaluations, root cause investigations, and relevant training.

• Actively engage in various manufacturing projects, including process development, cost-saving measures, and quality enhancement initiatives.

• Gather and analyze quality indicators for monthly and quarterly assessments.

• Assist in the creation of documentation, including specifications for manufacturing or scientific test outcomes.

• Support the management, implementation, and documentation of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

• Participate in cross-functional teams focused on continuous quality improvement projects.

• Engage in the Internal Audit process and help address any observations.

• Identify quality improvement parameters by determining relevant statistical methods applicable to manufacturing processes.
Required Qualifications
  • Bachelor's degree in biomedical, chemical, or mechanical engineering
  • 5-7 years of experience in quality engineering (PFMEA, Root cause analysis, scrap reduction, 5-whys)
  • Experience in Manufacturing Validation (IQ, OQ, PQ)
  • Background in Medical Device industry
Preferred Skills
  • Strong analytical mindset
  • Leadership capabilities
  • Proven ability to drive continuous improvement
  • Experience in team management and coaching
Work Environment

Onsite position with standard working hours.
About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We assist innovative companies in advancing their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market. With a network of nearly 30,000 consultants and over 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 fundamental to the equity and success of our workforce. DE&I are embedded into our culture through:
  • Hiring diverse talent
  • Maintaining an inclusive environment through ongoing self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our employees
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.