The Quality Systems Manager plans, coordinates, and directs Quality Assurance programs designed to ensure continuous production of products consistent with established standards by performing the following duties personally or through subordinates.
Essential Duties and Responsibilities
Establishes and maintains Quality Assurance programs, procedures, and controls.
Participates in the development of policies and procedures to achieve specific goals.
Ensures that performance and quality of products conform to established company and regulatory standards.
Manages directly, or through subordinates, Quality Control support activities (Production, Receiving Inspection, Finished Goods, and Calibration).
Ability to understand and interpret technical documents and specification drawings.
Knowledge of GD&T.
Acts as advisor to subordinate staff to help meet established schedules or resolve technical or operational problems.
Manages Corrective and Preventive Action system including initiating, coordinating investigations, close-outs, and verification methods.
Determines equipment qualification, process validation (IQ, OQ, PQ and MVP), and product line design/modifications requirements. Drafts protocols and reports and analyze data.
Asses proposed quality system changes ensuring they are compliant.
Advises Manufacturing on installation and maintenance of inspection and testing procedures for raw materials, packaging materials, components and finished products.
Formulates and maintains Quality Objectives and coordinates objectives with Manufacturing to maximize product reliability and minimize costs.
Develop data collection process/methods and analyze data.
Works with Manufacturing and Quality Engineering to provide feedback to production personnel regarding accuracy of assembly procedures.
Responsible for Supplier Management Process including performing supplier audits.
Works with Contract Facilities Management to establish and maintain effective environmental monitoring systems.
Manages audit program, acting as the company’s representative during external audits and performing internal audits to ensure compliance.
Manages responses to all nonconformities raised during audits.
Plans, promotes, and organizes training activities related to product quality and regulatory compliance.
Responsible for ensuring investigation of customer complaints.
Develops strategies to ensure continuous improvement in the ability to design and manufacturing quality products.
Maintains an up-to-date knowledge in the techniques of Quality Assurance/Quality Control and in the company products and process technologies.
Responsible for ensuring that subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
Acts as Management Representative for company.
Performs other duties as assigned.
Education/Experience Requirements
Minimum of 3 to 5 years experience in an FDA regulated industry and medical devices.
Demonstrates strong knowledge of quality systems.
Demonstrates an understanding of documentation systems, change control and electronic records.
21 CFR 820 and ISO 13485 knowledge.
Knowledge of EU MDD/MDR, ANVISA, TGA, JPMDL, CFDA
Bachelor’s degree in a scientific discipline or equivalent.
Ability to prioritize competing issues/projects.
Strong communication and organization skills required.
Works well cross functionally and has the ability to interpret requirements as well as educate others on those requirements.
Experience with problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
Good judgment skills within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Normally receives no instructions on routine work, general instructions on new assignments.
