Are you an experienced Quality and Compliance Director who is passionate about the role technology can play in making a difference in the world? Are you an experienced individual who enjoys working in a fast-paced, team-oriented environment, likes to be challenged, and values the opportunity to make a difference?
Carolina Precision Technology is looking for an individual who will be responsible for maintaining compliance with regulations, ensuring that its products meet the highest standards of quality, and meet and exceed all customer service goals.
Company Overview: Carolina Precision Technologies (CPT) is a premier, full-service precision manufacturer for the medical and aerospace industries. We are a market leading manufacturer of implants, specialty surgical instruments, cutting tools, and delivery systems for the orthopedic, sports medicine, trauma, extremities and other MedSurg applications.
Duties and Responsibilities
Carolina Precision Technologies (CPT) is seeking a Quality and Compliance Director to oversees all aspects of Manufacturing Quality, Regulatory and Compliance for Carolina Precision Technologies.
- Oversees all aspects of quality department for Carolina Precision facilities
- Understands and practices Quality System Requirements & applicable documentation
- Ensures that company, customer, and regulatory requirements are rolled out to and understood by all operational functions
- Ensures that company, customer, and regulatory requirements are met
- Responsible for certifications and regulatory compliance for all facilities
- Responsible for responding to customer inquiries related to quality and regulatory issues
- Communicates and acts as liaison with customers and vendors for all quality related issues
- Leads KPI improvement activities
- Coordinates corrective and preventive actions, as required
- Dispositions deviant product when necessary
- Performance evaluation/training effectiveness to be assessed following probationary period
- Proven track record of 3 to 5 years experience in quaility/regulatory management
- Bachelor’s degree or equivalent in experience or related training
- Quality experience in a formal quality management system essential, preferably ISO 13485 and/or AS9100
- Computer knowledge and organizational skills
- Good written and verbal communication skills
- Ability to work well as part of a team
- Excellent organizational skill
No agency calls please