Quality & QMS Manager, ISO/FDA Compliance Lead

ATALYS; Asheboro (NC); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

401(k) with company match

Medical, Dental, Vision

Disability Coverage

Life Insurance

Jury Duty Pay

Paid Holidays

Performance Awards

Job summary

ATALYS is seeking a Quality Manager to lead our QMS efforts in Asheboro, NC, ensuring ISO and FDA compliance across production, QA/QC, and distribution. You will drive risk analyses, CAPA, audits, and continuous improvement across the organization.

You will partner with cross-functional teams to meet quality goals, maintain certifications, and prepare for regulatory audits. A strong background in medical device quality systems and robust documentation is essential.

Qualifications

• Experience designing and maintaining QMS processes.
• Regulatory compliance experience in medical devices.
• Strong documentation and record-keeping practices.

Responsibilities

• Plan, coordinate, and implement QMS processes to meet ISO/regulatory requirements.
• Lead PFMEA and risk analysis programs across products and processes.
• Coordinate quality resources across projects to ensure on-time quality.
• Maintain QMS certifications and conduct internal/external audits.
• Own CAPA system and drive corrective actions to completion.
• Interface with regulatory auditors and customer quality requirements.
• Monitor trends and drive continuous improvements in quality.
• Oversee supplier quality and production quality interfaces.

Skills

Quality management

Regulatory compliance

Audits

CAPA

IQ/OQ/PQ

Root cause analysis

Project management

Leadership

ISO 9000

ISO 13485

FDA QSR/cGMP

Documentation

Education

BS in engineering or related discipline

MS degree a plus

Job description

ATALYS is seeking a Quality Manager to lead our QMS efforts in Asheboro, NC, ensuring ISO and FDA compliance across production, QA/QC, and distribution. You will drive risk analyses, CAPA, audits, and continuous improvement across the organization.

You will partner with cross-functional teams to meet quality goals, maintain certifications, and prepare for regulatory audits. A strong background in medical device quality systems and robust documentation is essential.