Lead Quality Assurance Engineer

2 weeks ago


Charleston, West Virginia, United States Kaztronix Full time
Position Overview:

The Senior Quality Engineer will play a pivotal role in ensuring the highest standards of quality within our organization. This position requires a comprehensive understanding of quality assurance processes and regulations in a regulated industry.

Key Responsibilities:
  • Implement and maintain quality assurance protocols to ensure compliance with industry standards.
  • Conduct thorough documentation and technical writing in accordance with regulatory requirements.
  • Collaborate effectively with cross-functional teams to foster a culture of quality and compliance.
  • Analyze data and utilize statistical tools to drive continuous improvement initiatives.
  • Facilitate risk management strategies and apply various mitigation tools to enhance product quality.
Qualifications:

Required:
  • Bachelor's degree in Engineering, Biology, Science, Chemistry, or a related technical discipline.
  • A minimum of 4 years of experience in a regulated environment, such as medical devices or pharmaceuticals.
  • In-depth knowledge of Quality Systems Regulations (QSR), Design Control, and Good Manufacturing Practices (GMP).
  • Exceptional verbal and written communication skills, with the ability to present complex information to leadership.
  • Proven experience in documentation and technical writing within a compliance-focused setting.
  • Strong teamwork and collaboration skills in a diverse environment.
  • Demonstrated initiative and ability to work independently.
Preferred:
  • Advanced degree in a relevant field.
  • Previous experience in a Quality or Quality Engineering role.
  • Understanding of pharmaceutical GMPs.
  • Experience with statistical analysis tools, such as Minitab.
  • Familiarity with Test Method Validations, Root Cause Analysis, CAPA & Non-Conformance Management, and Process Validations.
Work Environment:

This position requires a commitment to working on-site for a minimum of three days a week. Kaztronix is dedicated to creating an inclusive workplace and is an equal opportunity employer, ensuring fair treatment for all employees and applicants.

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