What are the responsibilities and job description for the Director/Manager, Operations Quality position at Access Vascular?
Job Description
Job Description
JOB DESCRIPTION
The Director / Manager of Operations Quality is responsible for leading the Operations Quality team at AVI. This is a collaborative position working closely with Operations and NPI Quality to support production management, production initiatives, and new product transfers from NPI to Operations while ensuring compliance with AVIs Quality Management System (QMS) and FDA Quality System Regulation (QSR) requirements.
DUTIES & RESPONSIBILITIES
- Lead the Operations Quality group of Quality Engineers and Quality Assurance and Quality Control technicians.
- Quality System owner of Nonconformances (NCR), Corrective and Preventive Action (CAPA), Equipment Controls, Process Deviations, Operations Quality Record compliance
- Responsible for the environmental monitoring program at AVI.
- Oversee the equipment control and calibration programs.
- Manage incoming Quality Control inspection.
- Identify and lead continuous improvement activities to enhance AVIs Quality Systems and manufacturing, inspection and testing processes.
- Participate in internal quality audit program.
- Prepare and act on Key Quality Performance Indicators
- Develop and implement ways to improve Quality Systems business processes and strategies, which increase efficiency, improve compliance, and reduce system maintenance requirements.
- Manage inspection readiness of all operations areas.
- May lead Customer Complaints and Change Control among other systems.
- Manages team performance management processes for direct reports, including goal and objective management and tracking. Contributes to budgetary processes, including efficiency opportunities, in collaboration with leadership
- Willing to be a hands-on contributor within the manufacturing Quality team.
QUALIFICATIONS
Physical Demands :
The physical activities described within the job posting are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Access Vascular, Inc is a proud Equal Opportunity / Affirmative Action Employer . All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status or disability status.
About Access Vascular
Access Vascular was founded in 2015 to address the most common and costly complications of intravenous therapy : infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications. .