Quality & Compliance Leader — Medical Device QMS

CSafe; Cincinnati (OH); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

PTO starting at 25 days

Medical, Dental and Vision Insurance

401k with Employer Match

Group Life & Disability Insurance

Tuition Reimbursement

Referral Program

Job summary

CSafe in Cincinnati, OH is seeking a Quality Manager to lead the Quality Management System, ensuring FDA, ISO 9001/13485, CE compliance, and overall quality excellence across Manufacturing, Engineering, Supply Chain, and Regulatory teams.

You will supervise Quality Engineers and maintain supplier quality, manage audits, CAPA, and quality metrics, driving risk mitigation and continuous improvement across the organization.

Qualifications

• Bachelor's degree in technical or scientific field; advanced degree preferred.
• Experience with FDA/ISO quality standards and audits.
• 5+ years in Quality System and Compliance, with managerial experience.

Responsibilities

• Management Representative of the Quality Management System; develop, improve, and implement key quality system processes to ensure compliance with ISO 9001, ISO 13485, CE, TGA, and FDA 21 CFR 820.
• PRRC for medical devices; ensures device conformity to the quality management system and harmonized standards.
• Ensures development, communication, implementation & maintenance of best-in-class quality management tools & principles.
• Defines, communicates, and gains cross-functional support for the site's Quality System and compliance strategy to mitigate product and compliance risk.
• Designs and implements effective quality processes including procedures, doc systems, CAPA, complaints, tools, reporting metrics and measurable improvements that are required to meet quality system standards and customer requirements.
• Interface with customers, suppliers, and agencies as necessary.
• Supervision of Quality Engineers and/or Technicians.
• Manage the quality of a network of 3rd party manufacturing and distribution locations.
• Manages Quality performance of our suppliers.

Skills

Regulatory compliance

Quality management

FDA/ISO audits

Leadership

CAPA

FMEA

Cross-functional collaboration

Education

Bachelor's degree in technical or scientific field

Engineering degree

Advanced degree preferred

Job description

CSafe in Cincinnati, OH is seeking a Quality Manager to lead the Quality Management System, ensuring FDA, ISO 9001/13485, CE compliance, and overall quality excellence across Manufacturing, Engineering, Supply Chain, and Regulatory teams.

You will supervise Quality Engineers and maintain supplier quality, manage audits, CAPA, and quality metrics, driving risk mitigation and continuous improvement across the organization.