Quality Assurance Engineering Manager jobs in Lowell, MA

Job Title: Manager of Quality Assurance
Industry: Biotechnology
Functional Area: Quality Assurance

Minimum Requirements:

• 5-8 Years of Quality Assurance Management Experience
• Bachelors Degree
• ISO 13485 experience required
• Proficiency in conducting QMS audits within a regulated setting.
• Skilled in drafting standard operating procedures, quality assurance protocols, work instructions, and documentation
• Comprehensive understanding of legal and regulatory standards at all levels

Role Summary:
As the Quality Assurance Manager, you will be instrumental in maintaining our commitment to quality and compliance. This includes adherence to regulations set by the FDA, ISO, ASTM, and the European Medical Device Regulation. Your role will be central to the continual development and improvement of our QMS, aligning with both our operational objectives and the evolving landscape of industry regulations.

Primary Responsibilities:

• Regulatory Compliance: Ensure all products, processes, and services comply with necessary regulatory standards, including but not limited to the FDA, ISO, ASTM, and European Medical Device Regulation.
• QMS Leadership: Drive the development, implementation, and ongoing refinement of our Quality Management System, ensuring it remains effective and responsive to changes in operations and regulations.
• Proactive Quality Management: Lead efforts in product conformity assessments and the execution of corrective actions stemming from QMS audits, aiming for zero repeat non-conformances.