Quality Manager

Seeking a hands on quality manager with experience in FDA, ISO13485, and MDD regulated quality system for medical device and software application business. This is a position in an early stage company that has been growing at a rapid pace with advancement opportunities.

Required Skills/Experience

BS degree in a technical area

3-5 years experience in medical device quality system design/maintenance

FDA/ISO audit experience

 Lead the Design control and V&V documentation efforts

Good writing and communication skills

Experience with ISO compliant documentation

Ability to operate in a fast paced environment

Desired Skills/Experience

510(k) submissions

Technical Files

Drafting skills a plus

Experience with EDC software

Responsibilities

Implement and maintain ISO compliant quality system

Lead company quality objectives

Participate in Design and Development activities