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 ensur ing compliance with AVIs Q uality Management System (QM S ) 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.