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
- Supplier qualification
- 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
- Benefits offered
- 401K, Dental, Life, Medical, Vision
Interested candidates email Samantha Pena at firstname.lastname@example.org.