Quality Assurance (QA) Specialist Medical Device Manufacturing - Katalyst Healthcares & Life Sciences

Responsibilities & Requirements:

• Minimum of 4-6 years of experience in quality assurance within the medical device manufacturing industry.

• Strong knowledge of validation protocol and other relevant medical device standards.

• Experience with process validation, risk management, CAPA, RFA, and validation protocols in a manufacturing environment.

• Excellent understanding of Quality Management Systems (QMS) and regulatory requirements in the medical device industry.

• Strong problem-solving skills with a focus on root cause analysis, CAPA, and continuous improvement.

• Ability to work collaboratively with cross-functional teams and communicate effectively at all levels of the organization.

• Proficient in using quality tools like Six Sigma, PFMEA, and statistical process control (SPC).

• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar certifications.