Reglera

Position Summary:

The Quality Assurance Manager is responsible for the effective implementation of Reglera’s Quality Assurance processes within Reglera and with Reglera’s external clients. Activities performed include Quality System implementations, process improvement programs, audits, validation, and CAPAs (corrective action and preventive action).

Education, Training, and Skill Recommendations/Requirements:

• Requires college degree in related field such as chemical or mechanical engineering.
• Requires a minimum of two years of quality assurance management, preferable in the medical devices and/or pharmaceutical industries; 5 years of quality assurance management is preferred.
• Excellent written and verbal communication skills
• Excellent skills in managing technical and human resources in a variety of projects.

Essential Functions: The Quality Assurance Manager has the following responsibilities:

• Day-to-day management, development, and implementation of quality assurance programs used within Reglera and for external clients
• Responsible for the ongoing review, strategy development, and operational planning to ensure that all quality assurance programs meet applicable regulations and standards
• Management and implementation of quality assurance objectives on an annual basis in accordance with Reglera’s corporate objectives.
• Ensure internal projects are completed on time and meet Reglera’s quality standards
• Ensure contractual deliverables are met with each client to its satisfaction
• Participate in industry trade shows, conferences, meetings, and publications to provide an active Reglera industry presence as required.

Other Responsibilities:

• Responsible to guide and collaborate with other quality managers, quality engineers, and engineering interns.
• Responsible to identify training and resource gaps to the appropriate Reglera quality director.