Quality Supervisor: CAPA & Compliance Leader

Nissha Medical Technologies; Buffalo (AL); On-site; USD 65,000 - 75,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company match

Paid time off

Life and disability insurance

Professional development opportunities

Job summary

Nissha Medical Technologies is seeking a Quality Supervisor to lead the Quality team in Buffalo, NY and maintain the Quality Management System to ensure adherence to FDA 21 CFR and ISO 13485 requirements.

The role involves oversight of CAPAs, audits, and documentation, with close collaboration across departments to improve processes and product conformity. Bachelor’s degree and supervisory experience are preferred, with a competitive compensation package.

Qualifications

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

Quality supervision

FDA 21 CFR knowledge

ISO 13485 knowledge

Leadership

Communication

Attention to detail

Education

Bachelor’s degree

Job description

Nissha Medical Technologies is seeking a Quality Supervisor to lead the Quality team in Buffalo, NY and maintain the Quality Management System to ensure adherence to FDA 21 CFR and ISO 13485 requirements.

The role involves oversight of CAPAs, audits, and documentation, with close collaboration across departments to improve processes and product conformity. Bachelor’s degree and supervisory experience are preferred, with a competitive compensation package.