Quality Engineer - Medical Devices, Onsite in Buffalo

JMS Technical Solutions; New York (NY); On-site; USD 86,000 - 105,000; Full time

Job summary

Tapecon, a top medical device manufacturer in Buffalo, NY, is seeking a Quality Engineer to support a high‑compliance manufacturing environment. You will lead corrective actions, support audits, and ensure products meet regulatory and customer requirements, collaborating with engineering, production, and customer teams to drive continuous improvement.

The role requires a Bachelor’s degree, experience in regulated manufacturing, and a strong command of ISO/FDA standards, data‑driven problem

Qualifications

• Bachelor's degree required; technical discipline preferred.
• Experience in a regulated, high-compliance manufacturing environment.
• Strong understanding of quality principles, ISO/FDA standards, and data-driven problem solving.
• Proficiency in Microsoft Office/365 and statistical analysis tools (Six Sigma experience preferred).
• Strong communication, organization, and collaboration skills.

Responsibilities

• Manage the complaint and corrective action program, ensuring clear documentation, accountability, and timely resolution.
• Lead containment, root cause analysis, corrective/preventive actions, and verification of effectiveness.
• Support product, process, and equipment validations, including protocol creation, testing, and documentation.
• Execute quality portions of Engineering Change Orders and support PFMEAs, control plans, PPAPs, and FAIs.
• Provide coaching and support to quality technicians, including calibration, inspection, and testing activities.
• Perform internal audits and support external audits, including corrective action follow-up.
• Monitor QMS performance, identify trends, and recommend improvement projects aligned with quality goals.
• Develop and revise quality documentation and train personnel on standards and procedures.

Skills

Quality principles

Data-driven problem solving

Communication skills

Regulatory compliance

Education

Bachelor's degree in a technical field

Tools

Six Sigma

Microsoft Excel

MS Office 365

Job description

Tapecon, a top medical device manufacturer in Buffalo, NY, is seeking a Quality Engineer to support a high‑compliance manufacturing environment. You will lead corrective actions, support audits, and ensure products meet regulatory and customer requirements, collaborating with engineering, production, and customer teams to drive continuous improvement.

The role requires a Bachelor’s degree, experience in regulated manufacturing, and a strong command of ISO/FDA standards, data‑driven problem