New opportunity available with our medical device client for a Director of Quality Control.
In this role, you are responsible for ensuring the quality management system is established, implemented, and maintained in accordance with relevant regulatory standards and established procedures.
Looking for someone with 10 years of quality experience in the medical device industry along with at least 7 years in a leadership role.
Quality control oversight duties will include:
- Oversees all aspects of Quality from the perspective of internal resources, supplier’s base, and customers. Manages Quality control and Quality Engineering teams.
- Ensure Quality Management System is established, implemented, and maintained in compliance with all regulatory standards
- Ensure Quality Management System supports current business priorities and improves upon it to enable and support the company's growth
- Measure, track, and report on quality objectives and report on performance of the quality management system and any needed improvements or quality issue
- Resolve deficiencies in the quality management system and implement a culture of continual improvement
- Manage and maintain all quality record such as laboratory certifications, documents, proficiency data, external audits, reports, training records, corrective action reports, change control, internal audits, customer complaints, etc.
- Bachelor's degree or higher in science or engineering-related field
- At least 10 years of quality assurance experience in medical devices with at least 7 years of leadership experience.
- Experienced in transforming and improving Quality processes, systems and culture with a demonstrated track record of process and productivity improvement and successful results with developing and implementing change initiatives
- Expertise in cGMP, ISO, FDA and other global medical device regulations
- Excellent communication and presentation skills
- Strong leadership and influencing skills
- Strong change management and transformation skills; team oriented work ethic
- Experience leading FDA and other agency regulatory inspections a plus
Director of Quality Control - 21006