Senior Supplier Quality Engineer

Job Description

As Senior Supplier Quality Engineer you will become a key part of our wider Manufacturing and Supply team. You will work closely with our technical, engineering and product development teams, leveraging your knowledge of supplier development principles and supplier quality engineering to positively influence both new product development and manufacturing efforts.

This role reports into the Director of manufacturing and Supply Chain and will play an integral part in ensuring our ability to deliver Ori’s mission of enabling widespread patient access to lifesaving treatments.

Key Responsibilities

•  Apply knowledge of supplier development principles and supplier quality engineering to positively influence new product development efforts
• Work with production and supply base ensuring all verification, validation and review processes are robust and consistent
• Actively engage with all partners across Manufacturing and Supply, concerning the execution of necessary Quality Plans and Risk Management activities
• Work with all relevant Manufacturing & Supply stakeholders both internally and externally to facilitate corrective action
• Monitoring and reporting of quality metrics in the areas of Manufacturing and Supply to include driving delivery of all production and supplier NCR, CAPA & RCA works
• Working closely with production/suppliers to facilitate smooth and speedy completion of all engineering DfX exchanges aimed at better product and service quality
• Create a culture of continuous improvement

Experience

• Experience in supplier quality engineering / development as related to new product design and development in a regulated environment, preferably medical device
• Working knowledge of electronics, mechanics and software
• Development and/or interpretation of technical documentation, e.g., Quality Agreements, Quality Plans, Manufacturing Protocols and Technical drawings
• Some knowledge of medical device regulations, MDR, MDSAP, ISO 13485 and other global laws and regulations and standards including 21 CFR Part 820, ISO 14971 (including FMEA, DFMEA, PFMEA), IEC 60601-1, IEC 62304, IEC 62366 and related particular standards
• Demonstrable experience managing suppliers including supplier based working
• Familiarity with document management system, software, internal auditing is an advantage

Skills

• Strong commercial acumen, and customer focus
• Ability to work in and lead multi-disciplinary teams
• Thrive working in a dynamic start-up environment
• A dynamic and proactive outlook with strong problem-solving skills
• Passionate about enabling patient access to life-saving cell and gene therapies