Job Description

Join to apply for the Quality Assurance Specialist role at Katalyst CRO .

Responsibilities:

• Ensure compliance with Quality Management Systems (QMS) and regulatory requirements in the medical device industry.
• Implement and monitor CAPA, conduct root cause analysis, and drive continuous improvement initiatives.
• Collaborate effectively with cross-functional teams and communicate at all organizational levels.
• Utilize quality tools such as Six Sigma, PFMEA, and SPC to enhance processes.

Requirements:

• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification.
• 4-6 years of experience in quality assurance within the medical device manufacturing sector.
• Strong knowledge of validation protocols and relevant standards.
• Experience with process validation, risk management, and CAPA in a manufacturing environment.

Additional Details:

• Seniority level: Mid-Senior level
• Employment type: Contract
• Industry: Pharmaceutical Manufacturing

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