Quality Engineer Job in Pinbluff 28373, North Carolina US

ATEX Technologies, Inc., a growing medical textile component manufacturer located in Pinebluff, NC, is seeking a dynamic, confident, and multi-tasking quality engineer.  This individual is a self-starting achiever, who wants to make a difference.  This individual needs to excel working independently or in a team environment, and be comfortable in a fast paced setting.  This position will ensure performance and quality of finished products, components, and raw materials, and ensure conformance to established company and regulatory standards.

 

Job Qualifications/Responsibilities:

·         BS in Engineering, Science, Textiles, Biomedical or related field of study

·         Minimum of 4+ years of Quality Engineering is required

·         Quality management systems experience, especially industry-specific requirements; medical device – class III industry with a working knowledge of ISO:13485 a plus 

·         Lead product and process risk assessment

·         Knowledge of SPC, FMEA, MSA, and Control Plan development

·         Ability to work with team to gather information to write Validation Protocols, Final Reports, Master Plans for Process Validation and Product Qualifications

·         Conduct data collection, data analysis, and trending

·         Assist and/or lead in thorough investigations of quality issues and effective corrective and/or preventative action

·         Working knowledge of IQ, OQ, PQ validations

·         Lead product scale-up for process capability and statistical relevancy

·         Expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production and process controls; Corrective Preventive Action (CAPA), complaints risk management; product quality improvement and root cause analysis.

·         Software Validation and Design of Experiments (DOE) experience a plus

·         Must possess a strong sense of urgency, teamwork, keen attention to detail, ability to plan, organize and multi-task. 

 

If you are an experienced quality professional looking to make a large impact within an organization this may be the opportunity for you.

 

 

Drug Screening, Post-offer Physical Examination Criminal Background Search Required

EOE and Drug-Free Workplace.