Quality Assurance Manager — ISO 9001/13485 Leader

SUHNER USA; Rome (GA); On-site; USD 90,000 - 130,000; Full time

Job summary

Suhner USA is seeking a Quality Assurance Manager to lead the Quality Management System and ensure ISO 9001 and ISO 13485 compliance in a manufacturing environment serving automotive, medical, and outdoor power equipment customers.

The role requires strong leadership, high organization, and ability to drive CAPA, audits, and data‑driven improvements on the production floor. Collaboration with Engineering and Operations is essential.

Qualifications

• Bachelor’s degree in Engineering, Quality, or related field (or equivalent experience).
• 5+ years of quality leadership experience in a manufacturing environment.
• Strong working knowledge of ISO 9001 and ISO 13485.
• Experience with regulated industries (medical and/or automotive preferred).
• Proven root cause and corrective action experience (8D, 5 Why, Fishbone, etc.).
• Strong understanding of SPC, inspection methods, and process validation.
• Excellent organizational and communication skills.

Responsibilities

• Maintain and continuously improve ISO 9001 and ISO 13485 compliant systems.
• Lead internal and external audits (customer, registrar, regulatory).
• Ensure document control, records management, and training compliance.
• Oversee CAPA, nonconformance, and corrective action processes.
• Drive risk management and quality planning activities.
• Serve as Suhner USA Quality Management System Representative for automotive, medical, and OPE customers.
• Lead response to customer complaints, 8D reports, and corrective actions.
• Ensure compliance with applicable regulatory and customer-specific requirements.
• Support PPAP and FAI submissions and validation activities where applicable.
• Manage supplier quality oversight and performance monitoring.
• Manage the quality portion of the RFQ process by submission of a QC feasibility.
• Work directly on the production floor to resolve quality issues.
• Lead root cause analysis using structured problem-solving tools.
• Support process validation, first article inspections, PPAP, SPC system monitoring and capability studies.
• Partner with Engineering and Operations to improve process capability and reduce defects by providing statistical data.
• Review and approve inspection plans and quality documentation.
• Responsible for the calibration system.
• Lead, coach, and develop Quality Technicians and Inspectors.
• Promote accountability, teamwork, and continuous improvement.
• Establish measurable quality goals aligned with company objectives.
• Report KPIs and quality performance to leadership.
• Drive data‑based decision making using SPC and trend analysis.
• Reduce scrap, rework, and customer returns.
• Improve inspection efficiency and process controls.
• Support lean manufacturing initiatives.

Skills

ISO 9001 knowledge

ISO 13485 knowledge

Root cause analysis

8D problem solving

5 Why analysis

Fishbone diagram

SPC understanding

Manufacturing leadership

Excellent communication

Education

Bachelor’s degree in Engineering, Quality, or related field

Job description

Suhner USA is seeking a Quality Assurance Manager to lead the Quality Management System and ensure ISO 9001 and ISO 13485 compliance in a manufacturing environment serving automotive, medical, and outdoor power equipment customers.

The role requires strong leadership, high organization, and ability to drive CAPA, audits, and data‑driven improvements on the production floor. Collaboration with Engineering and Operations is essential.