Plans, develops, maintains, and manages the Quality Control program, with direct involvement with Regulatory Affairs, Product Development, Validations, Operations, Sales and Marketing, and Purchasing in matters concerning Quality control inspection, supplier qualification, validation, product stability, and documentation.
Ensures that products released to the market meet the desired quality specifications and attributes through engineering analysis and testing. Ensures all corporate standards.
1. Directs and facilitates training on QMSs.
-Directs economic implication analyses, prepares reports of findings and carries out
complicated implementation and training assignments.
-Directs the operations for QMS. Conceptualizes and directs standards and methods for inspection, testing, and evaluation.
2. Quality Regulations, Standards, and Processes
-Plans and directs activities concerned with development, application, and maintenance
of quality standards for processes, materials, and products.
-Ensures verification testing of medical devices using proven methods under design
-Standardizes and optimizes product testing and inspection procedures and supervise
the QC inspection group, as applicable.
3. Quality Metrics
-Interacts with Product Development and Operations to assure statistically based quality
systems intended for use in the quantitative measurement of process variability.
-Participates in risk analysis for product designs and processes. Responsible for
improvement to products through the results of failure analysis.
-Maintains the non-conformance system and design systems for tracking and trending
of non conformances.
4. Supplier Audit/Qualification (selection & maintenance process)
-Planning: organizes audit team, schedule, scope of audit, communication
-Lead auditor for supplier audits.
-Prepares and distributes audit reports and assessment results (scores, etc.)
-Follows up with corrective actions and implements continuous surveillance
-Organizes/files supplier quality records as described in SP procedures (supplier
qualification form, audit report, CAPA matrix, quality manual, regulatory certificates...etc)
5. Initiates & coordinates quarterly supplier rating
-Evaluates Quality section in supplier rating
-Trains suppliers and evaluators on system tool, relevant processes, etc.
-Maintains suppliers on regulatory compliance (ISO, FDA…etc) as necessary