The Director of Quality Assurance establishes, maintains, controls, and improves the Quality Management System (QMS) to comply with applicable standards and regulations. The individual ensures consistent adherence to processes, procedures, and generation of necessary records to ensure the QMS is effective.
Essential Duties and Responsibilities
Ensures the established QMS complies with all applicable quality, safety, environmental, product and other related standards and regulations.
Constantly monitors worldwide changes and updates to standards, directives, norms, and regulations that may impact the QMS or the company’s ability to supply product throughout the world.
Manages and continuously improves the QMS.
Acts as the designated FDA Management Representative.
Organizes management review meetings, proposes quality objectives, and monitors the effectiveness of the QMS.
Coordinates internal quality audit activities and acts as Management Representative for external quality audits.
Oversees the Complaint Handling process and, if necessary, manages response to adverse events.
Oversees the Corrective and Preventive Actions processes.
Supervises the Document Control Department, monitors the Change Control Process, manages and controls all records.
Supervises the Quality Control Department to conduct incoming, in-process and final inspection of goods.
Works with Engineering and Purchasing to qualify new suppliers and monitors existing suppliers.
Conducts quality training for all new hires. Regularly provides training to promote excellence and adherence to the QMS.
Works with Engineering to provide support during the design development process. Reviews and approves all validation protocols and reports.
Assists with related special projects, as required.
To perform the job successfully, an individual should demonstrate the following competencies:
Communication – able to communicate clearly in written and oral format to a variety of audiences; represents the company with external parties in collaborative and negotiated relationships.
Detail Oriented – double-checks the accuracy of information and work product to provide accurate and consistent work; expresses concern that things be done right, thoroughly, or precisely; completes all work according to procedures and standards.
Problem Solving - identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions; uses reason even when dealing with emotional topics.
Leadership – exhibits high ethical values and excellent leadership skills, along with a demonstrated ability to organize and direct major work activities and administrative operations; shows an ability to plan, organize and manage a large, complex and highly skilled department; possesses strong analytical, organizational, inter-personal and management skills.
Project Management - coordinates projects; communicates changes and progress; completes projects on time and budget.
Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.
Reasoning Ability - ability to define problems, collect data, establish facts, and draw valid conclusions; ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Bachelor's degree preferably in Science with minimum of 5 years related experience in a structured quality management role. Preferred experience in medical related field.
Prior experience with manufacturing operations.
Experience with Quality System Documentation and good documentation practices.
Detailed knowledge of ISO 13485, ISO 14971, ISO 9001, 21 CFR 820, 93/42/EEC, 98/79/EC, and FDA UDI requirements.
Additional Salary Information: Commensurate with Experience
The ELITechGroup is a privately held group of worldwide manufacturers and distributors of in vitro diagnostic equipment and reagents. By bringing together IVD specialty companies that offer innovative products and solutions, ELITechGroup has become a major contributor in advancing clinical diagnostics to laboratories in the proximity market, those operating closer to the patient.
The ELITechGro...up manufactures and distributes diagnostic products for clinical chemistry, microbiology, immunology, and molecular biology though direct sales and a distribution network encompassing more than 100 countries.