CAPA leader - replacement for maternity leave

The Quality Assurance Engineer leading the CAPA elements at the site is responsible for providing guidance for CAPA process in accordance with documented procedures and practices.

Develop and maintain systems, procedures, and processes to ensure fulfillment of internal and external requirements. Ensures compliance to applicable standards and regulations. Has knowledge of best practices including vast knowledge in CAPA methodologies.  

Roles and Responsibilities

We are looking for an enthusiastic and passionate CAPA leader to take a central role in our QA team and support site CAPA activities. As part of your role, you will:

• Manage and oversees functional processes for the CAPA System and Metrics Reporting. Monitors and evaluates all site CAPA records to ensure procedure requirements are met. Metrics reporting to include monthly CAPA review Board.
• Handle and coordinate Risk Management activities (experience with ISO 14971 preferred)
• Take a leading role in external audits and internal audits

·       Interfaces with R&D, Regulatory Affairs, Clinical, Process Development and Manufacturing functions in a project team environment

·       Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.

• Acts as a resource for colleagues with less experience. May lead local improvement projects and be part of global projects/initiatives. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.
• Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).
• Uses judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions.

Requirements

• B.Sc in Mechanical / Biomedical / or similar from a known academic institution.
• 5+ years of hands-on experience in a similar role in a multi-disciplinary medical device company (Hardware, Software, Mechanics), working according to the MDR and CFR 21 Part 820, ISO 13485 regulatory requirements, ISO 14971, IEC 62304, IEC 60601
• Demonstrate in depth experience and understanding of product development lifecycle and design control activities (including Risk Management, design input/output, verification and validation etc.) in a medical device environment
• Experience with cross functional project teamwork and collaboration with R&D, RA, QA, Product, Program, and Operations team members
• Strong interpersonal, written, and verbal communication skills (Hebrew & English)
• 3-5 years working experience in Quality Engineering in Medical Device company.
• Ability to analyze and resolve complex problems. Ability to document, plan and established design documents.
• Demonstrated understanding of product development lifecycles, design changes and document change control, process verification and validation methodologies, design transfer, and servicing in a medical device environment.
• Ability to multi-task & handle tasks with competing priorities effectively
• Excellent interpersonal relationship – team player and team -oriented.
• Demonstrated collaboration, negotiation & conflict resolution skills.
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.