Title: Quality Manager - Quality Lead
Company Summary:
We need of a Quality Manager - Quality Lead for a start up Medical Device company just outside of Philadelphia. We want you to have a Entrepreneur mindset with the ability to assess risk and to be a cross functional team member!
The Quality Manager will be responsible for:
- Must be able to manage the implementation and development of our Quality Management Systems (QMS) to ensure compliance with FDA QSR, ISO 13485:2016,
- Must be able to coordinate internal and external audits
- Ensure compliance to design control and risk management regulatory requirements
- Lead quality improvement efforts to further enhance quality systems and must be able to resolve quality issues
The Quality Manager should have the following qualifications:
- 10 + year's experience in a QA or quality capacity for a medical device company with Class II or Class III products. (Does not need prior management experience)
- Experience with Medical Device that include embedded firmware, software and electronics elements 3rd Qualification
- Hands-on experience managing a Quality Management System with the application and implementation of GMP/QSR/ISO 13485/MDD/MDR
- Excellent understanding the standard operating procedures for medical device batch release
- We want you to have the desire to be part of an entrepreneurial environment that is lean; willingness to roll up one's sleeves and be 'hands-on
If you are interested in learning more about this opportunity, please Apply Now!