Quality Assurance Manager - Medical Devices & Pharma

J.M. Murray Center, Inc.; Sherbrooke; On-site; CAD 57,000 - 71,000; Full time

Job summary

JM Murray Center, Inc. seeks a Quality Assurance Manager in Cortland, NY to lead the QA program for medical devices/pharmaceuticals. You will drive FDA/ISO compliance, maintain the QMS, and coordinate cross-functional efforts.

Responsibilities include developing procedures, managing CAPA, audits, supplier quality, and documentation control while collaborating with Operations and Quality leadership to ensure product safety and regulatory compliance.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Pharmaceutical Sciences, engineering or science.
• 8+ years of proven quality/engineering experience in a regulated industry.
• Experience with ISO 9001, 21 CFR 210/211, 21 CFR 820, ISO 13485.
• Ability to translate regulations into quality system processes.

Responsibilities

• Develop, maintain, and improve the QMS to FDA/ISO standards.
• Review and approve quality procedures and controlled documents.
• Lead nonconformances, CAPA, and change control activities.
• Manage batch records, master production/control records, and documentation.
• Monitor processes for compliance and effectiveness.
• Plan/validate processes, products, and cleaning validation.
• Support supplier quality, audits, and corrective actions.
• Prepare budgets, analyze variances, and drive cost-aware improvements.
• Coordinate internal and external quality audits and training.

Skills

Technical writing

Problem solving

Interpersonal skills

Regulatory knowledge

Communication skills

Team coordination

FDA regulations

Education

Bachelor’s degree in science

Tools

ERP

QMS software

Job description

JM Murray Center, Inc. seeks a Quality Assurance Manager in Cortland, NY to lead the QA program for medical devices/pharmaceuticals. You will drive FDA/ISO compliance, maintain the QMS, and coordinate cross-functional efforts.

Responsibilities include developing procedures, managing CAPA, audits, supplier quality, and documentation control while collaborating with Operations and Quality leadership to ensure product safety and regulatory compliance.