Share Email Opening Apply Now Title Quality Engineer  EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.   Description JOB PURPOSE: To ensure on-going product quality through implementation of quality system processes and procedures. ESSENTIAL DUTIES: Ensures regulatory requirements are met Understands all aspects of assigned production line(s) in order to help minimize scrap and complaints Implements improvements using the CAPA system Prepares written protocols and reports Responsible for managing and scheduling the routine sterilization validations. Writing, reviewing, approving sterilization technical protocols and report Assists with maintaining established departmental policies and procedures, objectives, and quality improvement, safety, and environmental standards. Performs a variety of tasks using experience and judgment Upholds Xeridiem vision and core values Performs other duties as required QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities) Required: Applicable Bachelor's degree and/or equivalent experience in a related field, and a minimum of 5 years directly related experience Has knowledge of commonly-used concepts, practices, and procedures within field, including regulatory affairs Ability to problem solve, identify errors and deficiencies and perform research with limited guidance Ability to apply knowledge to their job function using pre-established guidelines and instructions Knowledge of applicable standards for EtO sterilization (e.g. ANSI/AAMI/ISO 11135-1, ANSI/AAMI/ISO 11135-2) Accuracy, attention to detail, and thoroughness Proficient computer skills Proficient communications skills A certain degree of creativity and latitude Ability to comprehend and comply with company safety and quality standards Ability to follow oral and written instructions Preferred: Previous experience in Quality Assurance Rudimentary knowledge of statistics Medical device experience WORKING CONDITIONS: Works under general supervision. Primary job functions do not typically require exercising independent judgment. This position requires about 50% of time spent sitting and working on computer. The other 50% of time would be spent moving around on the Production floor where protective clothing is necessary.   Position Requirements   Location SPG - Tucson, AZ   About the Organization Based in Alpharetta, Georgia with multiple plants across the United States, Mexico, Costa Rica, Ireland and Malaysia, Spectrum Plastics Group is a North American leader in the development and manufacture of specialty medical plastic products. Only Spectrum Plastics Group has the product breadth, expertise and global reach to deliver critical medical plastics at scale. We deliver operational excellence, innovative solutions and a high level of execution resulting in what our customers value most: precision, performance and repeatability. Spectrum Plastics Group offers a full range of custom design, engineering and fabrication services, as well as meets the requirements of ISO 9001, ISO 13485, FDA, operating multiple Class 7 & Class 8 clean rooms. When medical plastics are critical, the industry trusts us. Specialties: High performance extrusion Tight tolerance extrusion Extrusion Precision injection-molding Micro-molding Medical tubing PVC tubing Silicone Packaging Finished Devices/Assembly Contract manufacturing Clean room Thermoplastic tubing extrusion Medical device Medical plastics Medical components Microbore extrusion Bioabsorbables Catheters   This position is currently accepting applications. Apply Now Follow us See who works here:

 

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