Quality Supervisor

Graham Personnel Services; High Point (NC); Presencial; USD 55 000 - 60 000; Tempo integral

Resumo da oferta

Graham Personnel Services is seeking a Quality Supervisor to uphold medical device quality standards and regulatory compliance. You will support QMS implementation, supervise inspectors, and drive CAPA projects across operations and engineering.

Qualifications include 2+ years in quality leadership, knowledge of GMP, ISO 13485, and FDA 21 CFR Part 820, with strong cross‑functional collaboration and problem solving.

Qualificações

• 2+ years of quality management or supervisory experience.
• Knowledge of GMP, FDA 21 CFR Part 820, ISO 13485 and applicable quality standards.
• Experience with Quality Management Systems (QMS) and audits or CAPA processes.

Responsabilidades

• Assist Quality Manager in establishing and maintaining QMS per regulatory requirements and ISO 13485.
• Develop and implement quality policies, procedures, work instructions, and documentation.
• Ensure processes and finished products meet quality standards and regulatory requirements.
• Drive continuous improvement by defining metrics, analyzing data, and recommending CAPA actions.
• Collaborate across departments to identify and mitigate quality risks in manufacturing and distribution.
• Supervise Quality Inspectors and the Quality Coordinator; oversee Supplier Quality workflows.

Conhecimentos

Quality mgmt

Supervisory

GMP

FDA 21 CFR 820

ISO 13485

QMS

Audits

CAPA

Leadership

Cross-functional

Regulatory awareness

Formação académica

Bachelor’s/Associate in Quality/Eng/Manufacturing/Life Sciences

Ferramentas

QMS software

Descrição da oferta de emprego

Quality Supervisor

Reports To: Quality ManagerSalary: 55K-60KJob OverviewThe 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.

QualificationsEducationHigh 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.

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