Quality Assurance Validation Specialist

2 weeks 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 core duties will involve evaluating and validating production methodologies, analyzing their measurement capabilities, assessing process capability, and executing enhancements to fulfill client specifications. 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 production processes and supervise all new client projects. Your proficiency will be vital in formulating quality enhancements, implementing cost-saving measures, and developing innovative analytical testing methods. This role demands a robust analytical approach, leadership abilities, and the capacity to foster continuous improvement in a fast-paced manufacturing setting.

• Ensure that product and process validations are thoroughly executed.

• Carry out material disposition for discrepancies with appropriate guidance.

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

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

• Actively engage in various manufacturing initiatives such as process innovation, cost efficiency, and quality enhancement projects.

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

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

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

• Participate in cross-departmental teams focused on ongoing quality improvement initiatives.

• Engage in the Internal Audit process and support the resolution of findings.

• Identify quality improvement metrics by applying statistical techniques relevant 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 capabilities
  • Leadership and mentoring skills
  • Proven ability to drive continuous improvement
  • Team management and coaching expertise
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 innovative companies in advancing their engineering and science projects by providing access to specialized experts who enhance 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 Fortune 500 companies.
Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are fundamental to the equity and success of our workforce. DE&I are integrated 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 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.

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