The Quality Engineer is responsible for the overall implementation, maintenance, and performance of the Quality Management System to ensure the highest levels of product quality. The QE is responsible for ensuring compliance with FDA Quality System Regulation (QSR), ISO 13485, and other applicable regulations. This role also provides support to product development and manufacturing, as well as contract manufacturing sites and external suppliers. Key areas of support include feedback and complaint management, design controls, verification and validation activities, risk management (ISO 14971), inspection and acceptance activities, calibration and preventive maintenance activities, internal and supplier audits, supplier evaluations, nonconformance investigation and resolution, product/process improvement, data analysis and trending, CAPA and change control management. This role will report directly to the Vice President of Operations.
Duties and Responsibilities:
* Develop, implement, and maintain quality system procedures, policies, and forms. Ensure training processes and methods are in place and effective
* Develop and implement receiving inspection processes and methods and provide technical support to inspection staff. Ensure unambiguous specifications are defined, inspection methods and equipment are adequate, and appropriate sampling plans are used
* Comply with FDA Quality System Regulations (QSR), ISO 13485, other regulatory requirements, company policies, procedures, and processes
* Support design, test, and inspection method development, and lead verification and validation activities where applicable
* Create and modify product and quality specifications, quality plans, risk analyses, and FMEAs to provide a high degree of assurance that processes will consistently produce product that meets specifications and regulatory requirements
* Contribute to product and process verification and validation activities for new/existing equipment and/or processes
* Monitor, control, and reduce process and product defects by leading efforts focused on identifying and eliminating the primary root causes through effective and timely management of CAPA activities
* Support manufacturing process development and qualification for new product introduction and product changes
* Contribute to supplier development activities by conducting evaluations, on-site supplier audits, assessing suppliers' technical capabilities, competency, and compliance to requirements, and developing and implementing improvements and process controls to minimize the risk of non-comformances
* Plan and lead audits of internal processes as required to ensure they remain compliant with established standards, provide support to the organization during 3rd party audits of the quality system. Drive activities to identify root cause and appropriate corrective actions as needed
* Provide guidance on data analysis and statistical tools to support data analysis, root cause analysis, failure investigation, and product and process risk management activities
* Provide technical support to internal and external customers, as needed, to support quality activities
* Other duties when identified
Experience and Qualifications:
* Knowledge of FDA Quality System Regulation (QSR) 21 CFR Part 820 and/or ISO 13485, ISO 9001:2015 experience is applicable
* Minimum of 3+ years of experience in quality assurance development, maintenance, and management
* Experience in manufacturing environment required
* Experience with Class I & II Medical Devices preferred
* Ability to read technical design drawings and understanding of GD&T
* Experience in medical device regulatory approvals (FDA De Novo and 510K, CE Mark & International) preferred
* Proficient with Microsoft Office Suite, especially Excel and Outlook
* BA/BS degree in engineering/scientific discipline or Quality Management or equivalent
Additional Salary Information: Company stock Options and bonus available based on performance.
Internal Number: FM01-002-01
About Smart Medical Devices, Inc.
Smart Medical Devices, Inc. ("SMD") is a company "of surgeons for surgeons". It is an innovator of revolutionary robotic tools designed to improve patient outcomes in orthopedic surgery. Located in Las Vegas, Nevada, SMD introduced its first product, the SMARTdrill 6.0 at the American Academy of Orthopedic Surgeons Annual Meeting in March 2019 with overwhelming success. SMD is currently securing distributors, sales agents, and internal team to meet the demands of orthopedic surgeons and hospitals.