Quality Supervisor
Reports To: Quality Manager
Salary: 55K-60K
Job Overview
The Quality Supervisor is responsible for supporting and maintaining quality standards for medical devices while ensuring compliance with applicable regulatory and quality requirements, including ISO 13485 and FDA 21 CFR Part 820. This position works closely with cross-functional teams, including Operations, Engineering, Customer Service, and other departments, to maintain product quality, support regulatory compliance, and drive continuous improvement initiatives.
Responsibilities and Duties
- Assist the Quality Manager in establishing, implementing, and maintaining an effective Quality Management System (QMS) in accordance with applicable regulatory requirements and ISO 13485 standards.
- Support the development and implementation of quality policies, procedures, work instructions, and related documentation.
- Ensure manufacturing processes and finished products meet established quality standards and applicable regulatory requirements.
- Drive continuous improvement initiatives by establishing quality metrics, analyzing performance data, identifying trends, and recommending corrective actions.
- Collaborate with cross-functional teams to identify, evaluate, and mitigate quality risks related to the manufacturing and distribution of medical devices.
- Supervise Quality Inspectors and the Quality Coordinator while overseeing Supplier Quality workflow and scheduling.
- Assist with developing and delivering quality training programs to ensure employees understand and follow established quality standards and procedures.
- Interview prospective Quality Inspector candidates and participate in hiring activities as needed.
- Oversee quality documentation, including procedures, work instructions, inspection records, and other quality records, to ensure accuracy and compliance.
- Coordinate and participate in internal and external audits to support compliance with applicable regulations and quality standards.
- Investigate product nonconformances and customer complaints, assisting with root cause analysis and corrective actions as appropriate.
- Conduct monthly performance reviews with Quality Control Inspectors.
- Coordinate the return and disposition process for nonconforming materials identified within Production and Warehouse operations.
- Support corrective and preventive action (CAPA) activities and ongoing quality improvement efforts.
- Perform additional duties and responsibilities as assigned by the Quality Manager.
Qualifications
Education
- High school diploma or equivalent preferred.
- Associate's or Bachelor's degree in Quality, Engineering, Manufacturing, Life Sciences, or a related field preferred.
Experience & Skills
- Minimum of 2 years of quality management or supervisory experience within a manufacturing environment.
- Knowledge of Good Manufacturing Practices (GMP), FDA 21 CFR Part 820, ISO 13485, and applicable quality standards.
- Working knowledge of Quality Management Systems (QMS).
- Experience supporting or participating in quality audits, nonconformance investigations, and corrective action activities.
- Strong organizational, prioritization, and problem-solving skills with excellent attention to detail.
- Ability to manage multiple priorities and responsibilities simultaneously.
- Strong written and verbal communication skills.
- Demonstrated leadership skills with the ability to supervise, train, and support quality personnel.
- Ability to work effectively across multiple departments and disciplines.
- Self-motivated with the ability to communicate quality concerns and address challenging situations professionally.
- Familiarity with regulatory affairs processes, including regulatory submissions, post-market surveillance, and labeling requirements, is preferred.
- Understanding of medical device technologies, manufacturing processes, and applicable quality standards is strongly preferred.
#DHIR26