Quality Supervisor

Nissha Medical Technologies; 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

About Nissha Medical Technologies

Nissha Medical Technologies (NMT) is a global Contract Development and Manufacturing Organization (CDMO) where people, purpose, and technology come together to advance healthcare. Headquartered in the United States, NMT is the medical devices business unit and a wholly owned subsidiary of Nissha Co., Ltd., a publicly traded Japanese company based in Kyoto, Japan (TSE: 7915).

Across our global organization, our teams collaborate to design and manufacture innovative medical devices and solutions that make a real difference in patients’ lives. We partner closely with our customers to solve complex challenges, move ideas forward, and support products from concept through commercialization. Our work spans patient monitoring, surgical and interventional solutions, precision components, and emerging technologies, all grounded in a strong culture of quality, accountability, and continuous improvement.

At Nissha Medical Technologies, we believe our success is driven by our people. We foster an environment where curiosity is encouraged, teamwork is valued, and individuals are empowered to grow their skills and careers. If you’re motivated by meaningful work, collaboration, and the opportunity to help shape the future of healthcare, you’ll find a place to belong at NMT.

What You Will Do

Nissha Medical Technologies is looking for a Quality Supervisor to join our Quality team in Buffalo, NY! This Position is responsible for the daily oversight of the Quality Control Inspectors/Specialists and monitoring/maintaining Quality Management System to ensure adherence to standards and regulations. Department oversight of internal audits, complaints, non-conformances, CAPAs, and document control. Personnel oversight includes payroll, performance reviews, and ongoing support for QC staff. Continuous collaboration with other departments to facilitate compliance and process improvement activities.

1. Oversees and approves documentation related to CAPAs, Non-conformances, complaints, and internal audits

2. Participates in the development of new and sustaining business

3. Review and creation of standard operating procedures and work instructions as necessary

4. Works to ensure specifications of product and customer requirements are met and compliant

5. Develops and executes departmental training related to quality processes

6. Tracks, trends, and analyzes departmental and organizational metrics

7. Recommends and configures new procedures as necessary

8. Manages assigned projects

9. Daily oversight of Quality Control members

10. Administer performance reviews and approves payroll for Quality Control Staff

What You Bring

Core Qualifications

• Bachelor’s Degree required

• Strong PC skills

• Experience FDA 21 CFR and ISO 13485 highly preferred

• Previous Quality experience

• Supervisory experience preferred

Preferred Qualifications

• Effective written and verbal communication

• Conflict resolution

• Detail oriented

Professional Traits We Value

• Interpersonal skills

• Leadership ability

• Time and Priority Management

• Critical thinking

Compensation & Benefits

The expected salary range for this position is $65,000-$75,000. Actual compensation will be determined based on experience, skills, qualifications, and geographic location.

In addition, Nissha Medical Technologies offers a competitive total rewards package including medical, dental, and vision coverage, 401(k) with company match, paid time off, life and disability insurance, and professional development opportunities.

Equal Opportunity Statement

Nissha Medical Technologies is an Equal Opportunity Employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected status under applicable law.