Knowledge | Experience | Skills
Bachelor's or Master's Degree in a relevant field of work and five plus years' experience in Medical Device Manufacturing. In-depth knowledge of ISO 13485 and 21 CFR 820. Experience with Quality techniques such as sampling plan development, statistical process control, inspection systems, instrument calibration, and design of experiments. Good communication and interpersonal skills. Good managerial and supervisory skills. Basic computer experience.
Essential Duties & Responsibilities
• Ensures Quality Management System is effective.
• Ensure systems compliance to maintain certification to ISO 13485.
• Responsible for managing site Master Validation Plan, new process validations, and maintenance of existing process validation including validation planning, protocol development and execution, data collection and analysis, and validation results reporting.
• Supports production personnel in the investigation of root causes and corrective actions of internal rejects, and implementation of corrective/preventive actions.
• Ensures CAPA system is maintenance and is effective.
• Administers the Customer Complaint Management system and ensures timely customer response, thorough root cause investigation, definition of corrective/preventative actions and completion of effectiveness checks before complaint closure.
• Immediately notifies Technimark Corporate Quality of any known or potential need for product recall or medical device reporting.
• Ensures internal and external audit findings are addressed in a timely manner and in accordance with customer and/or regulatory agency requirements.
• Oversees product inspection/metrology, functional and/or analytical testing, statistical analysis of result, reporting of results, and determination of acceptability.
• Responsible for the disposition of non-conforming products.
• Develop and administer quality training for all employees.
• Provides direction, training, and support to Quality Engineers and Quality Supervisors.
• Responsible authority for inspection, final disposition, and release of all products.
• Establish and maintain relationships with customers to address issues concerning product quality.
• Ensures trend analysis activities are conducted on periodic, recurring basis for proactive input to CAPA system and Continuous Improvement activities.
