Quality Assurance Manager

Direct Hire/Full Time

We are hiring for a Quality Assurance Manager (aka Manager, Quality Management Systems) for our Lexington, MA office.  In this role you will manage the day-to-day Quality Management Systems department activities and maintain full, ongoing compliance to all applicable U.S. FDA medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards. He/She will manage a small team (3-4) of quality assurance specialists.

Responsibilities:

• Manage and maintain full compliance to all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards
• Manage, train, develop and oversee the Quality Management System department staff and all related activities
• Manage the department (staff, tools, processes and workflow) and optimize for maximize productivity and compliance
• Capture monthly metrics (Key Performance Indicators), perform trending and ensure that metrics and trends meet department goals and objectives
• Perform day-to-day Quality Management System activities (Complaint Processing, Supplier Management, Nonconforming Material/Product, Equipment Management, CAPA, Statistical Analysis, etc.)
• Attend all department and company-wide team meetings as needed
• Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards

Qualifications:

• Minimum of a Bachelor’s Degree
• Five or more years of experience managing Quality Management Systems and the associated department staff in a regulated medical device company
• Five or more years of hands on experience performing Quality Management System activities in a U.S. FDA and ISO 13485 medical device regulated environment
• Deep knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806 and 21 CFR 807) and international standard requirements (ISO 13485/ISO9001, ISO 14971, IEC 62304 and the Medical Device Directive) highly desired