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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 evaluating and validating production workflows, analyzing their measurement capabilities, assessing process capability, and implementing enhancements to fulfill customer expectations. In your capacity as a team leader, you will oversee and mentor your direct reports, guiding them in their daily responsibilities and career growth. You will act as the site’s subject matter expert (SME) for validation within manufacturing operations and supervise all new client projects. Your proficiency will be vital in fostering quality enhancements, executing cost-reduction initiatives, and developing new analytical testing methodologies. This role demands a robust analytical mindset, leadership capabilities, and the drive to promote continuous improvement in a fast-paced manufacturing setting.

• Ensure completion of product and process validations.

• Execute material disposition for discrepancies with appropriate guidance.

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

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

• Actively engage in various manufacturing initiatives such as process enhancement, cost-saving measures, and quality improvement projects.

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

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

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

• Participate in cross-departmental teams focused on continuous quality enhancement projects.

• Engage in the Internal Audit process and aid in addressing findings.

• Identify quality improvement parameters by determining relevant statistical methods applicable to manufacturing processes.
Required Skills
  • 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 capabilities
  • Leadership qualities
  • Proven ability to drive continuous improvement
  • Experience in team management and mentoring
Work Environment

Onsite work schedule: Monday - Friday, 8am-5pm
About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We assist visionary 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:
  • Recruiting diverse talent
  • Fostering an inclusive environment through ongoing self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Providing growth opportunities for our workforce
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.