Spark Life Solutions, Inc.
Quality Assurance Engineer
Spark Life Solutions, Inc., Plano, Texas, us, 75086
Roles & Responsibilities:
Assist in the implementation and maintenance of the Quality Management System (QMS) documentation system and associated processes while ensuring compliance to applicable standards, regulatory and customer requirements and overall protection of company intellectual property.Guides the development, implementation, and evaluation of processes, procedures and applications contributing to the overall objectives of maintaining an effective quality program.Implement, maintain and continuously improve Quality Management System processes.Maximize the quality of the processes and the products these produce, while driving CAPA efforts.Improve and maintain processes for Document Control, CAPA, Nonconforming Material, Training and Complaints.Lead the organization in the development and use of the Risk Management Plan, FMEA and overall process development and execution.Implement, maintain and continuously improve the process to enhance product quality and process efficiency.Lead and manage the Internal Audit and Supplier Management processesEducation & Experience:
Minimum of 5 years of directly related work experience in Quality Assurance within the medical device, medical device software and/or biotechnology industries.Working knowledge of the FDA's QSR, ISO 13485, ISO 14971.Adheres to Good Manufacturing Practice (GMP)/Quality System Regulation (QSR) requirements and follows applicable QMS documentation such as Standard Operations Procedures (SOPs) and Work instructions to successfully accomplish job requirements.Strong understanding of quality management systems and regulatory requirements.
Assist in the implementation and maintenance of the Quality Management System (QMS) documentation system and associated processes while ensuring compliance to applicable standards, regulatory and customer requirements and overall protection of company intellectual property.Guides the development, implementation, and evaluation of processes, procedures and applications contributing to the overall objectives of maintaining an effective quality program.Implement, maintain and continuously improve Quality Management System processes.Maximize the quality of the processes and the products these produce, while driving CAPA efforts.Improve and maintain processes for Document Control, CAPA, Nonconforming Material, Training and Complaints.Lead the organization in the development and use of the Risk Management Plan, FMEA and overall process development and execution.Implement, maintain and continuously improve the process to enhance product quality and process efficiency.Lead and manage the Internal Audit and Supplier Management processesEducation & Experience:
Minimum of 5 years of directly related work experience in Quality Assurance within the medical device, medical device software and/or biotechnology industries.Working knowledge of the FDA's QSR, ISO 13485, ISO 14971.Adheres to Good Manufacturing Practice (GMP)/Quality System Regulation (QSR) requirements and follows applicable QMS documentation such as Standard Operations Procedures (SOPs) and Work instructions to successfully accomplish job requirements.Strong understanding of quality management systems and regulatory requirements.