Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities :
• Collaborate with design engineering to develop, review, and approve Design Inputs/Outputs, Design History File (DHF) documentation, and Change Control implementation.
• Ensure full compliance with design control standards such as 21 CFR 820 and ISO 13485.
• Act as SME for design controls, design verification & validation (V&V), process validation, test method validation (TMV), and risk management per ISO 14971.
• Plan and execute risk management activities including hazard analysis, dFMEA, and pFMEA throughout the product lifecycle.
• Conduct Failure Modes and Effects Analysis (FMEA) and integrate findings into design and manufacturing processes.
• Lead or support design verification and validation planning, execution, protocol creation, and report writing.
• Oversee test method validation, statistical testing, and process validation to ensure traceability and compliance.
• Develop, revise, and ensure adherence to QMS procedures covering ISO 13485, cGMP, and 21 CFR Part 820, including document control, CAPA, and audit readiness.
• Support internal and supplier audits, regulatory inspections, and ensure follow-up with corrective actions.
• Investigate product deviations and process non-conformances, lead root cause analysis, and implement CAPA or Client actions.
• Monitor the effectiveness of corrective actions and maintain relevant documentation.
• Qualify suppliers, review supplier documentation, and support pilot/production transfer to align with Critical to Quality (CTQ) requirements.
Requirements:
• Collaborate with manufacturing engineering to implement process improvements and validate manufacturing outputs.
• Stay current with relevant regulations (FDA, EU MDR, ISO 10993, etc.) and integrate best practices into quality systems.
• Provide regulatory submission support for 510(k) or similar filings.
• Educate engineering and manufacturing teams on design and quality requirements, quality tools, and compliance standards.