QMS Lead: Medical Devices Compliance & Improvement

Elliquence; Baldwin (NY); On-site; USD 95,000 - 105,000; Full time

Job summary

Elliquence is seeking a Quality Management Systems Supervisor to oversee the development, implementation, and maintenance of the QMS, ensuring ISO 9001, ISO 13485, and AS9100 compliance.

You will lead internal and external audits, drive CAPA, manage eQMS and document control, and mentor cross‑functional teams to sustain product quality and regulatory readiness.

The position reports to the Director of Quality Affairs and offers an opportunity to influence quality culture across the organization.

Qualifications

• Minimum 5 years in a leading Quality Management Systems or Quality Assurance role in medical devices.
• Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, Quality Management, or related field.
• Strong knowledge of ISO 9001, ISO 13485, or AS9100:2016 standards.
• Experience leading RCA, FMEA, SPC, and electronic QMS software.
• Lean Six Sigma Certification preferred (Black Belt/Green Belt).

Responsibilities

• Manage the QMS structure; ensure policies, SOPs, and work instructions are compliant.
• Lead internal and external audits; coordinate finding responses and verify CAPA effectiveness.
• Lead root cause analysis for non-conformances and customer complaints; implement CAPA.
• Drive continuous improvement using lean methodologies, SPC, and data analysis.
• Manage the eQMS and ensure document control is current and compliant.
• Develop and report KPIs to senior management to support data-driven decisions.

Skills

ISO 9001 / ISO 13485 knowledge

Auditing

CAPA management

Lean Six Sigma

SPC

eQMS software

Regulatory compliance

Education

Bachelor’s degree in Engineering or Life Sciences

Master’s degree in related QMS field (preferred)

Tools

eQMS software

Document control systems

FMEA tools

Job description

Elliquence is seeking a Quality Management Systems Supervisor to oversee the development, implementation, and maintenance of the QMS, ensuring ISO 9001, ISO 13485, and AS9100 compliance.

You will lead internal and external audits, drive CAPA, manage eQMS and document control, and mentor cross‑functional teams to sustain product quality and regulatory readiness.

The position reports to the Director of Quality Affairs and offers an opportunity to influence quality culture across the organization.