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Lead Quality Assurance Engineer

2 months ago


Charleston, West Virginia, United States Kaztronix Full time
Position Overview:
We are seeking a highly skilled Senior Quality Engineer to enhance our quality assurance processes within a regulated environment. This role is crucial in ensuring compliance with industry standards and fostering a culture of quality throughout the organization.

Key Responsibilities:
  • Implement and maintain quality systems in accordance with regulatory requirements.
  • Conduct thorough evaluations and analyses to ensure adherence to Quality Systems Regulations (QSR).
  • Collaborate with cross-functional teams to drive quality initiatives and improvements.
  • Prepare and present detailed reports to management, highlighting key findings and recommendations.
  • Engage in documentation practices that meet compliance standards, including technical writing.
  • Facilitate risk management assessments and develop mitigation strategies.
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 industry such as medical devices or pharmaceuticals.
  • Strong understanding of Design Control and Good Manufacturing Practices (GMP).
  • Excellent verbal and written communication skills, with the ability to effectively convey information to leadership.
  • Proven experience in documentation and technical writing within a compliance-focused environment.
  • Ability to work collaboratively in a diverse team setting.
  • Demonstrated initiative and ability to work independently.
Preferred:
  • Advanced degree in a relevant field.
  • Prior experience in a Quality or Quality Engineering role.
  • Familiarity with pharmaceutical GMPs.
  • Experience with statistical analysis tools, such as Minitab.
  • Knowledge of risk management tools and methodologies.
  • Experience with Test Method Validations, Root Cause Analysis, CAPA, Non-Conformance Management, and Process Validations.
Location: Somerset County, New Jersey.

Kaztronix is committed to equal opportunity employment and does not discriminate based on race, color, national origin, sex, age, religion, disability, veteran status, or any other protected status. All human resource actions are administered objectively and fairly.