CLIA Quality Leader for High-Complexity Diagnostics Lab

Nanobiosym; Cambridge (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

A biotech firm in Cambridge, MA is seeking a Quality Manager for its high-complexity testing CLIA lab. The role involves ensuring compliance with regulatory standards and leading the quality management program. Candidates should have a minimum of 8 years in an FDA regulated industry and experience in medical devices or in vitro diagnostics. Strong leadership, communication skills, and a thorough understanding of quality management systems are essential. This position offers the chance to work in a dynamic environment and interact with regulatory bodies.

Qualifications

• Minimum 8 years in an FDA regulated industry with regulatory body interaction.
• Experience in medical device and/or in vitro diagnostics industry required.
• Effective verbal and written communication skills, attention to detail.

Responsibilities

• Lead the CLIA quality management program in accordance with regulatory standards.
• Ensure laboratory audit readiness and manage clinical lab audits.
• Develop dashboards for reporting significant issues related to quality activities.

Skills

Regulatory compliance

Quality management systems (QMS)

Audit management

Interpersonal skills

Problem-solving

Education

Bachelor of Science degree in medical technology or laboratory sciences

Job description

A biotech firm in Cambridge, MA is seeking a Quality Manager for its high-complexity testing CLIA lab. The role involves ensuring compliance with regulatory standards and leading the quality management program. Candidates should have a minimum of 8 years in an FDA regulated industry and experience in medical devices or in vitro diagnostics. Strong leadership, communication skills, and a thorough understanding of quality management systems are essential. This position offers the chance to work in a dynamic environment and interact with regulatory bodies.