Quality Systems Lead - Medical Devices

Norwood Medical; Dayton (OH); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) plan

Life Insurance

Tuition assistance

Job summary

Norwood Medical seeks a Quality Manager to lead manufacturing quality teams and drive compliance with ISO 13485 and FDA 21 CFR 820. You will oversee quality projects, develop processes, and mentor staff to ensure product quality and regulatory readiness.

The role requires strong leadership, strategic direction across teams, and collaboration with engineers and operations to meet business goals, safety standards, and continuous improvement initiatives.

Qualifications

• Experience leading manufacturing quality teams.
• Knowledge of ISO 13485 and FDA 21 CFR 820 quality requirements.
• Proven ability to manage multiple quality projects and priorities.

Responsibilities

• Lead and mentor assigned quality teams to meet departmental goals.
• Oversee quality functions and projects within the team.
• Collaborate with leaders to align quality efforts with business strategies.
• Conduct research for new manufacturing quality processes.
• Manage career development and engagement of direct reports.
• Make final decisions to achieve business objectives in quality.
• Perform financial analysis of quality team impact.
• Uphold safety practices and safety-related activities.
• Maintain and improve the QMS to comply with ISO 13485 and FDA rules.
• Ensure customer requirements are understood and met and report to management.

Skills

Quality leadership

Quality systems

GD&T

Metrology

Cross-functional collaboration

Communication

Job description

Norwood Medical seeks a Quality Manager to lead manufacturing quality teams and drive compliance with ISO 13485 and FDA 21 CFR 820. You will oversee quality projects, develop processes, and mentor staff to ensure product quality and regulatory readiness.

The role requires strong leadership, strategic direction across teams, and collaboration with engineers and operations to meet business goals, safety standards, and continuous improvement initiatives.