Job Description
*No recruiters please
The Quality Manager is responsible for leading the manufacturing Quality group at AVI. This is a collaborative position working closely with Operations to support production management and production initiatives while ensuring compliance with AVIs Quality Management System (QMS) and FDA Quality System Regulation (QSR) requirements. This position is located in Billerica, MA, no relocation offered.
Duties & Responsibilities
- Lead the manufacturing Quality group of Quality engineers and Quality Control technicians.
- Quality System owner of Nonconformances (NCR), Corrective and Preventive Action (CAPA), Customer Complaints, and Change Control among other systems.
- Responsible for Medical Device Reporting (MDR) to the FDA.
- Responsible for the environmental monitoring program at AVI.
- Oversee the equipment control and calibration programs.
- Manage incoming inspection.
- Identify and lead continuous improvement activities to enhance AVIs Quality Systems and manufacturing processes.
- Support the internal audit program.
- Willing to be a hands-on contributor within the manufacturing Quality team.
Qualifications
- BS in related technical field, preferably Engineering
- 10+ years of Quality experience in the Life Science or Medical Device Industries
- Minimum of 2 years in a Managerial role.
- Embody the Access Vascular Guiding Principles
- Working knowledge of 21 CFR 820 and ISO 13485
- Ability to review and write technical documentation
- Self-initiator with strong organization skills
- Teamwork, flexibility and adaptability to change
- Ability to communicate and lead through influence
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. .
