MedTech Quality & Compliance Leader

5118 PERRY STREET NE, LLC; Marietta (GA); On-site; USD 90,000 - 120,000; Full time

Job summary

SoftWave TRT seeks a Quality Manager to lead the QMS and compliance framework, ensuring ISO 13485 and FDA QMSR readiness as the company scales. You will own CAPA, supplier quality oversight, audit leadership, and regulatory support across Operations, Engineering, Regulatory Affairs, and Service teams.

The role emphasizes cross-functional governance, document control, and continuous improvement to maintain regulatory credibility and robust quality systems during growth.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Quality, Operations, or related field.
• 7+ years of progressive quality experience in regulated manufacturing.
• 3+ years in medical device, diagnostics, or other highly regulated industry strongly preferred.
• Prior experience owning or administering a Quality Management System (QMS).
• Experience supporting FDA inspections and ISO 13485 certification audits.

Responsibilities

• Own and maintain the company’s QMS in alignment with applicable medical device standards.
• Develop, implement, and maintain procedures, SOPs, work instructions, and quality records.
• Manage document control, revision control, and training documentation processes.
• Ensure continuous audit readiness across all quality system elements.
• Lead the CAPA system including initiation, investigation, root cause analysis, and closure.
• Lead supplier qualification and quality oversight activities and manage SCARs.
• Lead internal and external audits, coordinate audit responses and corrective actions.
• Support Regulatory Affairs with submission documentation and compliance records.
• Manage engineering change control and quality record processes.
• Drive cross-functional accountability for issue resolution and process improvement.

Skills

Regulatory knowledge

QMS ownership

CAPA management

Audits

Document control

Education

Bachelor’s degree in Engineering, Life Sciences, Quality, Operations, or related field

Job description

SoftWave TRT seeks a Quality Manager to lead the QMS and compliance framework, ensuring ISO 13485 and FDA QMSR readiness as the company scales. You will own CAPA, supplier quality oversight, audit leadership, and regulatory support across Operations, Engineering, Regulatory Affairs, and Service teams.

The role emphasizes cross-functional governance, document control, and continuous improvement to maintain regulatory credibility and robust quality systems during growth.