Quality Assurance Specialist
4 days ago
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.
- 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.
- Master's degree in a related field.
- Experience with medical device or diagnostic lab equipment.
- Certification in quality management, such as CQI or CQE.
Katalyst HealthCares & Life Sciences offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
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