Quality Engineer - Katalyst Healthcares & Life Sciences

• The candidate will provide operational support and leadership for the NH site's Quality Management System (QMS) to ensure compliance to the regulatory and procedural requirements.
• in the manufacture of disposable medical products for Companies customers.
• They will assist the operations team in the establishment and implementation of programs designed to assure control of processes and products toward the established standards of quality under the companies QMS.
• This role is also responsible for leading the Quality Technician's to ensure proper support of the quality engineers and respective project teams.
• Understand and ensure compliance to the ISO 13485:2016, 21 CFR Section 820, MDD/MDR and Companies Quality System requirements.
• Act as the Companies quality interface for assigned customers and suppliers.
• Monitor customer complaints and trends. Respond as needed for failure investigation and specific corrective actions.
• As the Quality technical lead of a Value Stream Team, provide quality support to existing product/process issues, including NCMR's, MRB, root cause analysis, Deviations, test procedures and protocols.
• Conducts risk analysis for products and processes being transferred, following guidance under ISO 14971.
• Create Quality Plans and Master Validation Plans in support of customer product implementation.
• Develops verification and validation protocols supporting the implementation of products and processes into Companies clean room production environment.
• Manage customer deliverables and quality documents to an approved/released state.
• Interface with customer to drive improvements or changes.
• Active participant in customer business reviews, presenting key performance metrics.
• Supports audits performed by Notified Body and customers. Will perform/participate in audits of companies suppliers as required.
• Investigation and correction of internal, customer, and supplier quality issues.
• Coordinate efforts with Engineering and Manufacturing for the establishment of controls, which support current product designs, and process capabilities for assigned product lines.
• Provide mentorship and training to Quality Technicians to ensure they can adequately support operations and New Product Introduction (NPI) teams.
• Lead product, process and component root cause failure analysis with Engineering counterpart.
• Drive the CAPA process to completion on assigned corrective and preventive actions.
• Evaluation and approval of proposed changes to the Quality Management System, validations, and deviations.

Requirements:

• Required Skills, Knowledge and Expertise:
• Comprehensive understanding of ISO 13485:2016 and FDA Quality System Regulations (QSR)
• under 21CFR 820 as they pertain to the production of medical devices.
• Medical Device Directives and any necessary product specific applicable standards
• Understanding of ISO 14971 Risk and Hazard Assessment
• Strong Corrective Action skills including the ability to conduct Root Cause Analysis using Fishbone Diagrams and/or Fault Tree Analysis.