A dynamic, growing Class I / II medical global device manufacturer for dental products based in Houston, TX is seeking a highly skilled, high-impact Quality Assurance Manager to manage its quality systems, lead its quality initiatives and direct the activities of the Regulatory Team. The Quality Assurance Manager is responsible for management of all aspects of the quality management system, and worldwide regulatory compliance. The successful candidate will:
QUALITY MANAGER RESPONSIBILITIES
Work with department leaders to ensure adherence to the Quality System standards and processes, and applicable regulatory requirements:
Manage the Quality Management System including the Quality Manual, Procedures (QSP), Specifications, Test Methods, and Work Instructions.
Be the primary author for all Quality documentation.
Perform statistical analysis of data from all company processes, identifying negative trends and/or deficiencies as well as areas for improvement in products or processes and, working with department leaders and suppliers, correct deficiencies and improve quality
Lead Quality System Management Reviews
Manage the Regulatory Department
Manage all FDA Approval, ISO Certification, CE Certification, MDSAP and other country medical device certifications/licenses
Support OBL registration/license activities.
Serve as the Quality Management Representative, managing internal and Notified Body audits. Facilitate FDA inspections.
Control GUDID records.
Review marketing & advertising communication for regulatory compliance.
Currently holds at least one ASQ Certification (Certified Quality Manager, CQM, - Certified Quality Engineer, CQE, - Certified Quality Auditor, CQA)
At least 10 years’ experience in medical device industry managing a Quality System for FDA Class 2 devices, ISO 13485 Certification and CE Mark requirements.
At least 3 years management experience.
Highly proficient and accurate in writing and reviewing technical documents related to medical devices.
Excellent organization, verbal, written, and interpersonal skills.
Ability to multi-task, learn quickly, effectively manage time to meet deadlines.
Flexible for new assignments.
Demonstrated ability as responsible for safeguarding confidential information.
Proficient with computers and common business applications including Microsoft Office Suite.