Dynamic Sr. Quality Engineer to lead quality assurance activities ranging from product development through transfer to manufacturing and post market surveillance. Quality Engineer will apply diversified knowledge of engineering, software verification, supplier management and quality principles and practices for Class II medical devices and accessories.
Providing Quality expertise to cross-functional project teams and extended organization throughout the product life cycle.
Contribute to the overall quality initiative, including product quality assurance and quality control, from product concept to transfer manufacturing and post market surveillance.
Contribute to all aspects of design control.
Partner with appropriate functions in development and maintenance of Device Records (i.e. DHF, DMR)
Provide input into the development of inspection plans, quality agreements and supplier agreements.
Apply proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Develop inspection and sampling plans
BS in Engineering
5+ years of experience within product development for medical device
Design control experience
Thorough knowledge of FDA 21 CFR Part 820 regulations and ISO 13485 standards required
Experience with risk management and use of ISO 14971.
Practical application of statistical concepts including SPC techniques, hypothesis testing, DOE, and sampling plans
Demonstrated knowledge of QSR (21 CFR 820) / ISO Quality System (ISO 13485), FDA Software guidance of Verification & Validation
Understand and working knowledge of IEC 60601-1, IEC 62304, EN ISO 14971, IEC 62366-1, 62366-2, EN 556-1, EN ISO 11135, EN ISO 10993, ASTM D4169, FDA Software Guidance or similar standards, Soldering Standards (IPC-A-610)