Quality Assurance Specialist

4 days ago


South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full time
Job Summary

Katalyst HealthCares & Life Sciences is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for developing and implementing quality management systems and methodologies to ensure the highest level of product quality.

Key Responsibilities
  • Develop and implement quality management systems and methodologies to ensure compliance with regulatory requirements and industry standards.
  • Conduct gap analyses and identify areas for improvement in existing processes and procedures.
  • Develop and maintain quality documentation, including SOPs, policies, and forms/templates.
  • Support the development and implementation of quality training programs for employees.
  • Collaborate with cross-functional teams to ensure quality is integrated into all aspects of the business.
  • Conduct audits and assessments to ensure compliance with quality management systems and regulatory requirements.
Requirements
  • Bachelor's degree in a related field, such as engineering or quality assurance.
  • Minimum 5 years of experience in quality assurance or a related field.
  • Strong knowledge of quality management systems, including ISO 13485.
  • Experience with auditing and gap analysis.
  • Excellent communication and interpersonal skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
Preferred Qualifications
  • Master's degree in a related field.
  • Experience with medical device or diagnostic lab equipment.
  • Certification in quality management, such as CQI or CQE.
What We Offer

Katalyst HealthCares & Life Sciences offers a competitive salary and benefits package, as well as opportunities for professional growth and development.



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