Quality Engineer

  • Anywhere

Company :

Location :
Jupiter, Florida

Expiry Date :
Mon, 07 Dec 2020 23:59:59 GMT

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Description :
Quality Engineer ["United States-Florida-Jupiter"] The Quality Engineer will provide direct technical support for various quality system processes to help ensure excellent software product quality throughout product lifecycles. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Serve as a core team member on Hillrom cross-functional teams providing guidance regarding application of Hillrom quality procedures. * Conduct internal audits to ensure Regulatory compliance to good manufacturing practices (GMP) of medical devices and applicable regulatory agencies (i.e. FDA, Notified Bodies, etc). * Support external regulator and other external audits. * Develop, implement, and monitor quality initiatives, including supplier performance management, Quality Plans, process improvements, and cost reduction initiatives. * Collaborate with R&D Engineering and Regulatory Affairs to ensure that SaMD solutions adhere to applicable medical device regulations. * Analyze quality data to identify trends or issues requiring additional actions or CAPA activity. Institute quality tools and programs that focus on identification and prevention of quality defects. * Lead or assist in internal Corrective Action Preventive Action (CAPA) activities. * Assist in complaint/field return investigations related to purchased product. Analyze returned components, recommend corrective actions, and follow-up on suppliers response and implementation of corrective actions. * Review and approve engineering design changes and supplier change requests to determine part re-qualification needs. * Lead Material Review Board and non-conforming product processes. Prevent further shipments and/or processing of materials in the event of encountering non-conforming product from a supplier. * Participate in root cause/failure analysis of supplier-caused non-conforming product and ensure product quality concerns are adequately addressed by the supplier. * Interface with supplier s engineering and quality management teams to ensure that corrective & preventive action is implemented in a timely manner and is effective to prevent recurrence. * Escalate quality issues to management, as appropriate. * Must be willing and flexible for business travel as required. Travel required may be upwards of 10%. Knowledge of 21 CFR 820, ISO 13485, ISO 14971, IEC 60601-1 and IEC 62304 are desired. Three (3) to 5 years in a Quality Assurance, Manufacturing, and/or Engineering role, with a minimum of 2 years in Quality Assurance preferred. Experience in a medical device or other FDA regulated industry required. Bachelor of Science in Engineering or other related scientific or technical field. Understanding of quality assurance testing environments and software development lifecycles. Able to demonstrate excellent analytical and problem-solving skills. Excellent data analysis and presentation skills Proficient in the use of standard quality engineering tools Demonstrated tendency to put the customer first Exhibits strong collaboration skills and the ability to develop/maintain productive relationships to assure success on both current and new business initiatives. Ability to combine data, good judgment, and intuition to drive improvements and make timely business decisions. Able to operate somewhat independently, while motivating and driving team initiatives. Yes, 10 % of the Time Full-time