Quality Assurance Supervisor - CAPA & Compliance Leader

Regulatory Jobs; Buffalo (NY); On-site; USD 65,000 - 75,000; Full time

Job summary

Nissha Medical Technologies in Buffalo, NY is seeking a Quality Supervisor to lead the Quality team, oversee QC Inspectors/Specialists, and maintain the Quality Management System to ensure compliance with FDA 21 CFR and ISO 13485.

You will supervise payroll, performance reviews, training, and collaborate with other departments to drive continuous improvement and regulatory adherence. The role requires a Bachelor's degree and strong leadership in a medical device environment.

Qualifications

• Bachelor’s Degree is required.
• Strong PC skills are required.
• Experience with FDA 21 CFR and ISO 13485 is highly preferred.
• Previous Quality experience is required.
• Supervisory experience is preferred.

Responsibilities

• Oversees and approves documentation related to CAPAs, Non-conformances, complaints, and internal audits.
• Participates in the development of new and sustaining business.
• Review and creation of standard operating procedures and work instructions as necessary.
• Works to ensure specifications of product and customer requirements are met and compliant.
• Develops and executes departmental training related to quality processes.
• Tracks, trends, and analyzes departmental and organizational metrics.
• Recommends and configures new procedures as necessary.
• Manages assigned projects.
• Daily oversight of Quality Control members.
• Administer performance reviews and approves payroll for Quality Control Staff.

Skills

Strong PC skills

Experience FDA 21 CFR and ISO 13485

Previous Quality experience

Supervisory experience

Education

Bachelor’s Degree

Job description

Nissha Medical Technologies in Buffalo, NY is seeking a Quality Supervisor to lead the Quality team, oversee QC Inspectors/Specialists, and maintain the Quality Management System to ensure compliance with FDA 21 CFR and ISO 13485.

You will supervise payroll, performance reviews, training, and collaborate with other departments to drive continuous improvement and regulatory adherence. The role requires a Bachelor's degree and strong leadership in a medical device environment.