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.
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