QMS Supervisor - Medical Devices

Elliquence•Baldwin, NY

About The Position

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 in leading in internal/external audits, manage CAPA processes, and provide cross-functional training to enhance quality awareness.

Requirements

Minimum of 5 years of experience in a leading role in Quality Management Systems or Quality Assurance in the medical device industry required (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 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)
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.

Nice To Haves

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.

Responsibilities

Manage the QMS structure, ensuring all policies, procedures, and Work Instructions (SOPs) are compliant with regulatory requirements and align with company strategic goals.
With guidance from the Quality Affairs Director, 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.
Confirms 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.