Quality Assurance Validation Specialist

2 weeks ago

Franklin, Indiana, United States Actalent Full time

Position Title: Quality Assurance Validation Specialist

Role Overview:

As a Quality Assurance Validation Specialist, you will be instrumental in guaranteeing that our manufacturing operations adhere to the utmost standards of quality and productivity. Your key duties will include evaluating and validating production workflows, analyzing their measurement capabilities, assessing process efficiency, and implementing enhancements to fulfill client specifications.

Key Responsibilities:

  • Ensure comprehensive product and process validations are executed.
  • Oversee the disposition of non-conforming materials with appropriate guidance.
  • Propose inspection strategies, testing methodologies, and standard operating procedures.
  • Conduct sample size determinations, statistical evaluations, root cause investigations, and relevant training sessions.
  • Actively engage in various manufacturing initiatives, including process innovation, cost-saving measures, and quality enhancement projects.
  • Gather and analyze quality metrics for periodic reviews.
  • Assist in the creation of documentation, including specifications for manufacturing or scientific testing 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 ongoing quality improvement efforts.
  • Contribute to the Internal Audit process and aid in addressing any findings.
  • Identify quality enhancement parameters by applying relevant statistical techniques to manufacturing processes.

Required Qualifications:

  • Bachelor's degree in biomedical, chemical, or mechanical engineering.
  • 5-7 years of experience in quality engineering, including PFMEA, root cause analysis, and scrap reduction techniques.
  • Experience in manufacturing validation processes (IQ, OQ, PQ).
  • Background in the medical device industry.

Essential Skills:

  • Strong analytical capabilities.
  • Proven leadership abilities.
  • Capacity to foster continuous improvement.
  • Experience in team management and mentoring.

Work Environment:

This position requires onsite presence during standard business hours.

About Actalent:

Actalent is a premier provider of engineering and scientific services and talent solutions. We empower innovative companies to advance their engineering and science projects by connecting them with specialized professionals who enhance scale, innovation, and market readiness. With a vast network of consultants and a diverse client base, including many Fortune 500 companies, Actalent is committed to excellence.

Diversity, Equity & Inclusion:

At Actalent, we believe that diversity and inclusion are essential to the success and equity of our workforce. Our DE&I initiatives include:

  • Recruiting diverse talent.
  • Fostering an inclusive workplace through ongoing self-assessment.
  • Creating a culture of care, engagement, and recognition with measurable outcomes.
  • Providing growth opportunities for all employees.

Actalent is an equal opportunity employer and welcomes applications from all qualified individuals without regard to race, gender, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.

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