Design Quality Engineer II RPE Job Description
We are seeking a skilled Quality Engineer to join our team in the development of medical device products. The ideal candidate will have experience in quality engineering and a strong understanding of regulatory requirements.
* Critically review new or modified product designs to determine their impact on existing or new product requirements, patient safety standards, and compliance with regulations.
* Evaluate design changes to ensure they comply with Medtronics QMS ISO13485 EU-MDR FDA Quality System Regulations.
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Main Responsibilities:
• Review product designs for compliance with regulations
• Develop risk management files and risk assessments
• Lead cross-functional teams • Provide technical expertise in quality assurance. -----------------------------------
About This Role:
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out solutions. Our mission is to alleviate pain, restore health, and extend life. As part of this team you would be responsible for reviewing various medical devices while considering an array of variables such as materials used manufacturing process output delivery timelines etc... The successful candidate must be able to critically analyze information identify potential risks provide recommendations accordingly work effectively under pressure meet deadlines maintain high levels customer satisfaction through excellent communication interpersonal skills & collaboration efforts leading smooth teamwork results along job tasks!!