Position Description
This position is responsible for the day to day operations and/or the management of the quality system.
COMPETENCIES & RESPONSIBILITIES (included but not limited to):
- Organize and maintain Design History Records (DHR)
- Assist in marketing opportunities
- Develop, maintain, and implement a quality policy that maintains compliance with applicable Quality System Regulations.
- Complete Document Change Orders (DCO) document and control processes and procedures.
- Actively lead or assist activities in the following areas: Incoming Inspection, Non-Conforming material, CAPA (Corrective and Preventive Actions), Production support, Document Control, Quality Management Reviews, Quality Audits, DHRs, Product Complaints and other associated tasks.
- Work with suppliers, and Production Support personnel in eliminating problems via root cause analysis techniques, to ensure that product quality is monitored and maintained
- Stay informed on updates to standards and regulations
- Schedule and perform vendor qualifications and equipment calibrations
- Assist in the resolution, documentation, customer responses of product complaints.
- Participate in conducting internal/vendor audits.
QUALIFICATIONS:
- 4yr degree in applicable field of study, preferably science or engineering
- 2+ years experience in medical device industry
- Quality orientation and high attention to detail
- Ability to thrive in start-up environment
- Understanding of quality and regulatory requirements for Class 1 and Class 2 devices
- Excellent written and verbal communication skills
- Project management, self-starter and self-organizer
- Problem analysis and problem resolution skills
- Ability and eagerness to learn
