The Supplier Quality Engineer is responsible for maintenance of supplier related processes that enable manufacturing to produce the highest quality product for our customers. This person plays a critical role in ensuring suppliers’ quality systems and supplied materials meet quality standards consistent with RefleXion’s specifications and meet regulatory requirements. This person represents the RefleXion Medical Quality Assurance team at supplier locations and works with suppliers to ensure they have appropriate controls and quality process in place to ensure product reliability.
- Lead supplier selection, classification, approval, and development through a combination of audits and product or process qualifications.
- Support design control activities and new product introduction where supplier selection is required or existing suppliers are impacted, acting as liaison between RefleXion Medical and its suppliers.
- Maintain the Approved Supplier List (ASL) and generate supplier audit schedules annually and ensure execution of audits.
- Collaborate with suppliers in defining supplied material specifications, identifying critical component features and supplier manufacturing processes, developing and validating supplier manufacturing processes, and implementing appropriate process controls and monitoring.
- Assist suppliers with the development and implementation of statistical sampling plans and inspection procedures as needed.
- Monitor, review, and report on supplier performance, in-house and to suppliers (as needed), reporting trends.
- Perform failure investigations to determine the root cause of supplied material failures and recommend, implement and follow-up the initiation of Supplier Corrective Actions (SCAR)
- Serve as technical resource for process improvement projects such as alternative measurement/testing methodologies, supplier supplied data, and Master Lot/Skip Lot qualification programs.
- Assist in resolving internal and external audit findings and observations for Inspection Quality Control (IQC) and supplier controls program identifying and implementing corrective actions as appropriate.
- Serve as quality representative on the Material Review Board (MRB) to determine the appropriate disposition of NCR’s and required corrective action plans for discrepant material.
- Perform other duties as assigned.
- BS Degree in Engineering or related technical discipline or equivalent experience
- ASQ Certified Quality Engineer a plus and/or lead auditor certification a plus
- Minimum three 3 years experience in supplier quality with a minimum of 5 years experience in a medical device design, manufacturing, or quality engineering environment capital equipment.
- Evaluation of measurement systems and capabilities
- ISO 14971 Risk analysis including FMEA
- Strong communication skills, both written and oral
- Knowledge of and experience in manufacturing medical devices in conformance with FDA 820 Quality System Regulation and ISO 13485:2016 required