What are the responsibilities and job description for the Quality Assurance Engineer position at Genesys Spine?
Genesys Spine is looking for a mid-level Quality Assurance Engineer that wants to work in a dynamic environment. The ideal candidate must be willing to roll their sleeves up and execute while having the desire and potential to grow into a more senior role. At Genesys, the quality / regulatory personnel interface with all facets of the organization and must be willing to take on a leading role for a variety of tasks.
Job Description: Manage quality assurance for Genesys Spine’s medical devices throughout the product lifecycle. Implement and maintain the quality management system (QMS). Maintain an understanding of the standards that govern the design, development, testing, and management of medical devices and quality management systems. Revise procedures, as needed, to maintain compliance with the latest standards. Create regulatory strategies and write/submit regulatory submissions. Actively contribute to product development by generating Design Control deliverables. Be able to apply problem-solving methodologies and lead process improvement initiatives. All Genesys personnel must strive to meet or exceed customer expectations, by rapidly responding to their needs, while complying with all regulatory requirements and maintaining the effectiveness of the Quality Management System.
Responsibilities
Create, revise, and/or maintain all levels of QMS documentation, including, but not limited to:
- The Quality Manual
- SOPs, Work Instructions, etc.
- Management reviews
- Internal / external audits
- Supplier qualification and supplier audits
- Quality System metrics
- CAPA’s
- Training
- Nonconformance reports
- Complaints & MDRs
- Device History Records
- Engineering changes
- Labeling
- Design Controls deliverables
- Regulatory submissions and filings
Experience: 4 years of experience in quality and/or regulatory and/or product development of Class II medical devices.
We recognize that most candidates will not be experienced in all the listed areas, but they must be willing and capable of learning.