We have an immediate need for an experienced Quality Systems Manager to assist in new product introduction (NPI) and getting the company ISO 13485 certified.
You will guide our cross-functional product engineering teams (mechanical, chemical, photonics, software, and electrical engineers) on quality objectives, working to make this product a clinical and market success.
- BS, with a strong technical aptitude, Medical Device NPI experience.
- 5+ years of experience, ideally for a company developing complex catheter-based high-tech medical devices.
- Must have experience creating and implementing quality metrics and quality system to facilitate ISO 13485 certification.
- Working knowledge and use of IEC 60601 (safety and effectiveness), IEC 62304 (medical device software lifecycle processes), ISO 14971 (application of risk management to medical devices), and ISO 13485 (QMS), and other regulatory requirements as applicable to medical products with significant electronic and software content.
- Excellent leadership and communication skills and ability to communicate well in English, both written and spoken
Candidate must have a desire to work in a results-oriented culture that fosters team spirit, innovation, and a can-do attitude. It is also necessary to have the ability to work independently, in a team setting, and perform multiple simultaneous substantial projects.
The position is full-time and permanent. Salaries are competitive.
Women are encouraged to apply.