Quality Assurance Manager

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

The Quality Assurance Manager is responsible for leading and maintaining the company’s Quality Management System (QMS) in compliance with ISO 9001 and ISO 13485 standards while ensuring customer, regulatory, and internal quality requirements are consistently met.

This is a hands‑on leadership role within a manufacturing environment serving automotive, medical device, and outdoor power equipment customers. The ideal candidate is highly organized, detail‑oriented, team‑driven, and comfortable wearing multiple hats in a fast‑paced production setting.

Key Responsibilities:

Quality Management System (QMS)

• 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.

Customer & Regulatory Compliance

• 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 Request For Quote (RFQ) process by submission of a QC feasibility.

Production & Operations Support

• 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 to support data driven decisions.
• 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.

Required 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.

Preferred

• ASQ Certification (CQE, CQM, or equivalent).
• Experience with PPAP and customer audits.
• Experience in mixed industry manufacturing (automotive + medical).

Why Join Us

At Suhner, quality is at the core of what we do. As our Quality Assurance Manager, you’ll have the opportunity to:

• Lead a dedicated team
• Strengthen customer partnerships
• Grow professionally in a supportive environment

We value integrity, teamwork, and accountability—and we’re looking for someone who shares those values.

Suhner is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other status protected by law. We are committed to fostering an inclusive workplace and encourage individuals of all backgrounds to apply.