QMS Supervisor - Medical Devices

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

Quality Management Systems Supervisor

Job Summary

The Quality Management Systems Supervisor will oversee the development, implementation, and maintenance of the organization’s Quality Management System (QMS) to ensure compliance with industry regulations and standards (ISO 9001, ISO 13485, AS9100). Reporting to the Director of Quality Affairs, this individual will drive continuous improvement, support and lead internal/external audits, manage CAPA processes, and provide cross‑functional training to enhance quality awareness.

Key Responsibilities

• Manage the QMS structure, ensuring all policies, procedures, and Work Instructions (SOPs) are compliant with regulatory requirements and align with company strategic goals.
• Lead both internal and external audits (customer, registrar, regulatory), coordinate audit finding responses, and verify the effectiveness of corrective actions.
• Lead root cause analysis (RCA) for non‑conformances, customer complaints, and deviations, implementing effective Corrective and Preventive Actions (CAPA).
• Drive continuous improvement initiatives using lean methodologies, SPC (Statistical Process Control), and data analysis to enhance operational efficiency.
• Manage the electronic Quality Management Systems (eQMS) and ensure Document Control processes are current, accurate, and compliant.
• Confirm alignment of all Quality programs within the organization.
• Monitor and ensure the organization’s commitment to quality meets or exceeds customer requirements and the relevant regulatory standards.
• Develop, trend, and report key QMS performance metrics (KPIs) to senior management and provide solutions to guide data‑driven decision‑making.
• Develop training materials and educate staff on QMS procedures, GMP (Good Manufacturing Practices), or regulatory compliance to cultivate a culture of quality.
• Consistently review SOP and other services to improve quality and contain costs.

Required Qualifications

• Minimum of 5 years of experience in a leading role in Quality Management Systems or Quality Assurance in the medical device industry (spine or neuro device companies a plus).
• Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, Quality Management, or a related field. Master’s degree will be considered for 1 year work experience in a related QMS field in medical device industry (preferably spine or neuro).
• Strong knowledge of ISO 9001, ISO 13485, or AS9100:2016 standards.
• Leadership ability in root cause analysis tools, Failure Mode and Effects Analysis (FMEA), Statistical Process Control (SPC), and electronic QMS software.
• Certified Internal Auditor (ISO 9001/13485) preferred.
• Lean Six Sigma Certifications preferred (Black Belt and/or Green Belt).

Required Skills & Competencies

• Excellent written and verbal communication skills for interfacing customers and regulators.
• Proven ability to partner and influence cross‑functional teams, lead/mentor through collaboration and influence without direct authority.
• Strong analytical abilities to interpret data and implement effective, sustainable solutions.
• Proficient in problem solving with independent thought and judgement while using resources both internally and externally.
• Work efficiently and proactively cross‑functionally in a team setting while being sensitive to deadlines.
• High level of accuracy in document review and compliance assessment.
• Successful record of ability to work both independently and in a team environment.
• Skilled in statistical quality methods, Lean principles, Six Sigma, and Root Cause Analysis for data‑driven decision‑making.
• Determined and proactive mindset who is motivated to make a difference with a high standard of excellence.

Preferred Qualifications

• ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE).
• Experience in a heavily regulated industry (Medical Device or Pharma).
• Administration experience for document control.

Salary Range

95,000-105,000/annual

An employment offer is based on the candidate's professional experience, specialty, skillset, education, geography, related licenses or certifications, and other business needs. The compensation range indicated does not include other forms of compensation or benefits.

We value the diversity of our team and inspire creativity in our innovation. elliquence proudly provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state and local laws.

We are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need any reasonable accommodation due to a disability for any part of the application process, please email [e-mail].