Work Location: Baldwin County, New York
Summary:
The QMS Supervisor is responsible for overseeing the development, implementation, and ongoing maintenance of the Quality Management System (QMS) to ensure compliance with relevant industry standards and regulations. This role focuses on driving continuous improvement, managing audits, leading CAPA processes, and providing training to promote a culture of quality throughout the organization.
Responsibilities:
- Oversee the structure and maintenance of the QMS, ensuring all documentation and procedures comply with regulatory standards and organizational objectives.
- Lead and coordinate internal and external audits, manage audit responses, and verify the effectiveness of corrective actions.
- Conduct root cause analysis for non-conformances and customer complaints, implementing effective CAPA solutions.
- Drive continuous improvement initiatives using lean methodologies, statistical process control, and data analysis to optimize efficiency.
- Manage electronic QMS platforms and ensure document control processes are accurate, current, and compliant.
- Align all quality programs and initiatives across the organization to maintain consistent standards.
- Monitor compliance with customer and regulatory quality requirements, ensuring standards are met or exceeded.
- Develop and report key QMS performance metrics to senior management, providing actionable insights for decision-making.
Qualifications:
- Minimum 5 years of experience in a leadership role within Quality Management Systems or Quality Assurance, preferably in the medical device industry.
- Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, Quality Management, or a related field; Master’s degree may substitute for 1 year of experience.
- Strong knowledge of ISO 9001, ISO 13485, or AS9100:2016 standards.
- Experience with root cause analysis tools, FMEA, SPC, and electronic QMS software.
- Certified Internal Auditor (ISO 9001/13485) preferred.
- Lean Six Sigma certification (Black Belt or Green Belt) preferred.
- Excellent written and verbal communication skills for interfacing with customers and regulators.
- Proven ability to lead and influence cross-functional teams and mentor others.
- Strong analytical and problem-solving skills, with the ability to implement sustainable solutions.
- High attention to detail in document review and compliance assessment.
- Ability to work independently and collaboratively in a team environment.
- ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) preferred.
- Experience in highly regulated industries such as medical device or pharmaceutical sectors preferred.
- Experience with document control administration preferred.
Published Category: Quality & Validation