Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
Ensure compliance with applicable medical device regulations, quality standards, and Sterilmed client requirements.
Develop, implement, and maintain quality assurance processes and systems for medical device manufacturing.
Conduct root cause analysis, identify corrective and preventive actions (CAPA), and implement solutions for quality issues.
Review and approve design changes, process changes, and validation protocols/reports to ensure compliance with FDA and ISO standards.
Support sterilization processes and validations, ensuring adherence to established protocols.
Perform risk assessments (e.g., FMEA) to identify potential hazards and mitigate risks throughout the product lifecycle.
Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory, to maintain product quality and safety.
Assist in internal and external audits and ensure timely resolution of findings.
Monitor and analyze quality metrics to drive continuous improvement initiatives.
Ensure proper documentation in compliance with GMP, FDA, and ISO standards.
Requirements:
Bachelor’s degree in engineering, Life Sciences, or a related field.
3-5 years of experience in Quality Engineering within the medical device industry.
Strong understanding of FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards.
Experience with sterilization processes such as EtO, steam, or gamma sterilization is preferred.
Proficiency in quality tools and techniques such as CAPA, FMEA, and statistical analysis.
Strong problem-solving skills and attention to detail.
Excellent verbal and written communication skills.
Certification in Quality Engineering (CQE) or similar is a plus.
Hands-on experience with validation protocols (IQ/OQ/PQ).
Knowledge of Lean Six Sigma methodologies.
Familiarity with design control and risk management processes.