The Quality/Manufacturing Engineer will spend 50% of their time reviewing quality aspects of product lines, including: involvement in CAPA's, supplier quality and manufacturing quality. Remaining 50% will be spent planning, directing and coordinating manufacturing processes for medical device products and supporting Operations to improve existing processes to increase throughput or improve quality.
Essential Job Functions/Duties
- Performance of risk assessments, internal product and process non-conformances, quality investigations, independent projects and containment activities - Support/asses/develop continual improvement activities in response to non-conformances and other quality data metrics - Review/approve validations, test methods, protocols, monthly non-conformance reports, change requests, risk management files and other documents - Own or assist with internal investigations and CAPA's - Work with Quality Assurance and Production Engineering to verify/validate critical processes/products and apply control mechanisms around those processes/products so they can be effectively monitored - Trending of data and data analysis - Ensure compliance to quality system policies & department procedures - Maintain accurate timely reports and records
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization - Must strictly adhere to safety requirements - Maintain regular and punctual attendance - Must maintain company quality and quantity standards - Must have effective oral and written communication skills - Ability to work in collaborative and independent work situations and environments with minimal supervision - Ability to remain calm and receptive in fast paced situations - Must have excellent analytical and problem solving skills
Minimum Work Experience/Educational Requirements
- BS degree in engineering or related technical field; at least 5 years of experience in quality engineering, manufacturing engineering or development engineering - Knowledge of medical device regulations, pertinent standards and guidances - Knowledge of quality tools and principles
- Experience in project management and managing multiple activities preferred - Proven written and verbal communications skills - Proven problem solving skills
- Works under general office environmental and manufacturing conditions - Sitting or standing for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
“We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.”
Since 1963, Cook Group companies have been among the leaders in developing healthcare devices that have improved lives around the world. COOK remains at the forefront of medical research and worldwide sales of products for endovascular therapy, critical care medicine, general surgery, diagnostic and interventional procedures, bioengineered tissue replacement and regeneration, gastroenterology and ...endoscopy procedures, urology, and obstetrics and gynecology. COOK is a global company with a global focus - and a global future.
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