The Quality Assurance Specialist is responsible for providing Quality Assurance, Quality Control, and Preventative activity support for InGeneron’s Quality Management System. The Quality Assurance Specialist supports operations and other business functions with a focus on compliance to FDA and global quality system regulations and standards.
This is a hands-on role, with the opportunity to work across the full range of the QMS, including both product development and manufacturing, and supporting products from project initiation through to manufacturing and post market surveillance. Reporting to the Director of Quality and located in our Houston, TX office, the position may have approximately 10% travel, generally to the US, though to include the EU.
Contribute to cross-functional teams as the quality assurance representative at all phases of the product lifecycle
Ensure adherence to and drive improvement in company QMS procedures
Participate in Risk Management activities, in accordance with ISO 14971
Review and approve change management activities
Contribute to change control, document control, design reviews and design documentation
Establish and maintain KPI’s for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
Review and process post market surveillance information
Work closely with contract manufacturers on all quality related issues
Lead CAPA and NCMR processes, drive improvement of these and like processes
Provide quality representation during internal and external audits
Support and drive compliance to QSR and MDR regulations
Support material release
Bachelor’s Degree in biology, health science or engineering, or Associates with 3+ years experience
2+ years’ quality assurance experience, preferably within the medical device industry
Experience with ISO 13485, 21CFR820, MDD/MDR and ISO 14971
Excellent verbal and written communication skills
At InGeneron Inc, Houston, TX
401K, Dental, Life, Medical, Vision