As member of the Quality Engineering team, you will be expected to work beside other parts of the AED organization to promote a quality culture and compliance to all regulatory requirements of a Class 3, PMA device, specifically for validating large software systems. Review designs, documents, records, for compliance to internal procedures and regulations. This role will partner with other members of the team to ensure the deliverables are compliant to internal Philips Quality System requirements and initiatives, as well as all applicable regulations and standards.
Review and coordinate with Validation team and ensure work product meets regulations. Participate in phase reviews, write Quality Procedures, as applicable.
• Expertise in validation of enterprise wide quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines
• Experience in implementing systems compliant to 21CFR11
• Working knowledge of servers, databases, data migration, and server validation
• Understanding of software risk management (ISO 14971)
• Ensure validations verify data integrity, electronic data storage and data sheet validations.
• Team up with other members of the team to create plans for validating software systems to local site procedures
• Ensure deliverables are robust and meet regulations
• Knowledge of database and server management tools
• Lead quality assurance process from test design to final reports
• Good problem solving skills
• Significant leadership experience in role.
This role requires expert knowledge of ISO 13485, FDA’s QSR, ISO 14971, the EU’s MDD and regulations governing medical devices shipped to Canada. In addition, diplomacy, flexibility and critical thinking will be required in working closely with all parts of the organization, to ensure robust solutions are applied to processes. The ideal candidate is a self-motivated individual, who is excited by the prospect of working in a dynamic, fast-paced manufacturing environment, and has project management knowledge.
Additional requirements include:
• Bachelor’s or Masters degree plus a minimum of 10-20 years of related experience in the medical device or other regulated industry.
• Working knowledge of application development, testing, and deployment
• ASQ Software Quality Engineer certification preferred
• Must possess excellent communication (verbal & written) skills
• Able to exercise judgment against the criteria of applicable regulations and standards
• Proactive and able to act on own initiative
• Excellent organizational skills to manage and track deliverables applicable focused areas of responsibility
• Competent in the use of Microsoft Office programs