Quality Supervisor

Nissha Medical Technologies • Buffalo, NY

12d

About The Position

Nissha Medical Technologies is seeking a Quality Supervisor to join its Quality team in Buffalo, NY. The position provides daily oversight of Quality Control Inspectors and Specialists and monitors and maintains the Quality Management System to support compliance with applicable standards and regulations. The supervisor oversees internal audits, complaints, non-conformances, CAPAs, and document control, and provides personnel oversight for Quality Control staff, including payroll, performance reviews, and ongoing support. The role collaborates with other departments to facilitate compliance and process improvement, supports the development of new and sustaining business, and manages assigned projects.

Requirements

• Bachelor’s degree required.
• Strong PC skills.
• Previous quality experience.
• FDA 21 CFR and ISO 13485 experience highly preferred.
• Supervisory experience preferred.
• Effective written and verbal communication.
• Conflict-resolution skills.
• Attention to detail.
• Interpersonal skills.
• Leadership ability.
• Time and priority management.
• Critical thinking.

Nice To Haves

• Experience with FDA 21 CFR and ISO 13485.
• Supervisory experience.

Responsibilities

• Oversee and approve documentation related to CAPAs, non-conformances, complaints, and internal audits.
• Participate in the development of new and sustaining business.
• Review and create standard operating procedures and work instructions as needed.
• Ensure product specifications and customer requirements are met and compliant.
• Develop and execute departmental training related to quality processes.
• Track, trend, and analyze departmental and organizational metrics.
• Recommend and configure new procedures as necessary.
• Manage assigned projects.
• Provide daily oversight of Quality Control staff.
• Administer performance reviews and approve payroll for Quality Control staff.
• Monitor and maintain the Quality Management System and oversee internal audits, complaints, non-conformances, CAPAs, and document control.

Benefits

• Medical coverage
• Dental coverage
• Vision coverage
• 401(k) with company match
• Paid time off
• Life insurance
• Disability insurance
• Professional development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Manager