Quality Manager Job Description

Reports to CEO

Ormond Beach, FL Facility 

JOB SUMMARY: The Quality Manager leads and supports quality improvement initiatives throughout the organization. This role ensures that all processes and staff adhere to the quality management system and actively monitors its performance. The Quality Manager is responsible for developing and implementing quality goals and targets aligned with the organization's strategic plan, promoting continuous improvement, and ensuring compliance with relevant standards and customer expectations. 

 Regulatory and Compliance Management

·       Ensure adherence to all regulatory requirements, including ISO 13485 and FDA 21 CFR Part 820.

·       Oversee the health of the Quality System Regulations (QSR) and document control systems.

·       Manage the Corrective and Preventive Action (CAPA) system.

·       Coordinate internal and external audits to ensure compliance.

Customer Issue Resolution

·       Investigate and resolve customer complaints and issues related to quality.

·       Ensure customer requirements are accurately identified and that the company meets or exceeds expectations.

Quality Assurance Oversight

·       Supervise inspection activities across the product lifecycle.

·       Ensure tests and procedures are correctly understood, executed, and evaluated.

·       Recommend product modifications where necessary.

Quality Goals and Reporting

·       Develop quality goals and targets aligned with the company’s strategic plan.

·       Report key performance statistics related to quality measures.

Audit Support and Compliance

·       Support customer audits as primary contact and ensure corrective actions are implemented and maintained.

·       Ensure ongoing compliance with customer specifications and regulatory standards.

REQUIRED EDUCATION AND EXPERIENCE MIMIMUM QUALIFICATIONS:

·       BS, MS or MBA Degree from accredited University or a comparable amount of training, education or experience may be considered.

·       Must have medical device industry experience with QA/QC management experience.

·       Excellent knowledge of ISO, FDA and cGMP concepts, guidelines and regulations.

·       Thorough knowledge of a quality and regulatory system:

a.     CAPA - Corrective and Preventive Action

b.     SPC - Statistical Process Control charts and control charting concepts

c.     Trending analysis and reporting

d.     Document Control