Quality Leader: Medical Devices QC Supervisor

Nissha Medical Technologies; New York (NY); 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 in Buffalo, NY is seeking a Quality Supervisor to lead the Quality Control team and oversee CAPAs, audits, and document control. The role ensures compliance with FDA 21 CFR and ISO 13485 standards while driving process improvement and staff development.

You will supervise QC staff, manage payroll, performance reviews, and cross‑functional collaboration to meet product specifications and customer requirements.

Qualifications

• Bachelor's Degree required.
• Experience with 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 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 payroll for Quality Control Staff.

Skills

Strong PC skills

Effective written and verbal沟通

Conflict resolution

Detail oriented

Interpersonal skills

Leadership ability

Time and Priority Management

Critical thinking

Education

Bachelor's Degree

Job description

Nissha Medical Technologies in Buffalo, NY is seeking a Quality Supervisor to lead the Quality Control team and oversee CAPAs, audits, and document control. The role ensures compliance with FDA 21 CFR and ISO 13485 standards while driving process improvement and staff development.

You will supervise QC staff, manage payroll, performance reviews, and cross‑functional collaboration to meet product specifications and customer requirements.