Quality Manager - Medical Devices, ISO/FDA Compliance

CSafe Global; Monroe (OH); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Paid Time Off 25 days + Holidays

Medical, Dental and Vision Insurance

401k with Employer Match

Group Life & Disability

Tuition Reimbursement

Parental Leave

Gym Membership Reimbursement

Job summary

CSafe Global, based in Ohio, seeks a Quality Manager to lead the Quality Management System, ensuring FDA, ISO 9001, ISO 13485, CE compliance and driving continuous improvement across manufacturing, engineering and supply chain.

You will oversee PRRC responsibilities for medical devices, supervise QA engineers, implement CAPA and supplier quality programs, and elevate the overall quality maturity of the organization.

Qualifications

• Bachelor's degree in engineering or sciences.
• Experience with FDA/ISO quality standards and multiple ISO audits and FDA inspections.
• 5+ years in Quality System and Compliance with managerial experience.

Responsibilities

• Management Representative of QMS; develop, improve and implement quality processes to meet standards (ISO 9001, 13485, CE, FDA).
• Regulatory Compliance (PRRC) for medical devices; ensure conformity with requirements.
• Develop and maintain quality tools, CAPA, complaints handling, metrics and continuous improvements.
• Interface with customers, suppliers and regulatory agencies as needed.
• Supervise Quality Engineers/Technicians and manage supplier quality performance.

Skills

DOE

SPC

FMEA

DFMEA

Regulatory Knowledge

Leadership

Education

Engineering degree

Advanced degree preferred (Mechanical/Electrical/Reliability)

Job description

CSafe Global, based in Ohio, seeks a Quality Manager to lead the Quality Management System, ensuring FDA, ISO 9001, ISO 13485, CE compliance and driving continuous improvement across manufacturing, engineering and supply chain.

You will oversee PRRC responsibilities for medical devices, supervise QA engineers, implement CAPA and supplier quality programs, and elevate the overall quality maturity of the organization.