Quality Manager-Medical

Technimark•Asheboro, NC

43d

About The Position

This role is responsible for ensuring the effectiveness of the Quality Management System and compliance with ISO 13485. The Quality Manager will manage validation processes, support production in root cause investigations and corrective actions, and administer the customer complaint system. This position also involves overseeing product inspection, disposition of non-conforming products, quality training, and managing relationships with customers regarding product quality.

Requirements

Bachelor’s or Master’s Degree in a relevant field of work
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

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.