Medical Device Manufacturing Quality Lead

GI Windows Surgical; Canton (MA); On-site; USD 75,000 - 105,000; Full time

Job summary

GI Windows Surgical is seeking a Manufacturing Quality Specialist to support day-to-day operations on the manufacturing floor, ensuring products meet approved specs and regulatory requirements. This full-time role collaborates with Manufacturing, Engineering, and Quality to drive quality for implantable devices and delivery systems.

The MQS performs inspections, reviews documentation, analyzes data, and supports continuous improvement while adhering to GMPs.

Qualifications

• 2–5 years of experience in Quality within a regulated medical device environment.
• Knowledge of GMP, GDP, and quality systems in the medical device industry.
• Experience inspecting using inspection equipment and reading engineering drawings, specifications, and manufacturing documentation.
• Associate's or Bachelor's degree in Engineering, Life Sciences, Manufacturing, Quality, or related field.

Responsibilities

• Provide quality oversight on the manufacturing floor during production.
• Perform in-line and final inspections to verify conformance to specs.
• Review manufacturing docs for completeness and compliance with QMS.
• Develop and maintain manufacturing procedures, work instructions, travelers, and other production docs.
• Collaborate with Manufacturing and Engineering to improve processes and product quality.
• Analyze production and inspection data to identify continuous improvement opportunities.
• Investigate nonconforming products and assist with root cause analysis and CAPA.
• Ensure activities comply with GMPs, procedures, and regulatory requirements.
• Monitor processes for quality and efficiency improvements.
• Train production personnel on procedures and documentation practices.
• Assist with internal audits, external inspections, and QMS activities.

Skills

Quality Assurance

GMP Knowledge

Data analysis

Documentation

Problem-solving

Education

Bachelor's degree in Engineering or related field

Tools

Inspection equipment

Microsoft Excel

Job description

GI Windows Surgical is seeking a Manufacturing Quality Specialist to support day-to-day operations on the manufacturing floor, ensuring products meet approved specs and regulatory requirements. This full-time role collaborates with Manufacturing, Engineering, and Quality to drive quality for implantable devices and delivery systems.

The MQS performs inspections, reviews documentation, analyzes data, and supports continuous improvement while adhering to GMPs.