Description

Under minimal supervision from the Quality Manager, the Senior Quality Engineer will support Engineering and Quality Assurance activities and assist Quality Control and Regulatory as part of a comprehensive Quality Management System. ESSENTIAL DUTIES AND RESPONSIBILITIES - Read and conform to all company policies and procedures. - Interact and communicate with internal departments, including Purchasing, Shipping / Receiving, Engineering, Customer Service, and Sales/Marketing. - Authority to place product on hold. - Involved with new product development (NPD) process and the support of existing and previously commercialized products. - Review and approve engineering drawings and assist in determining Critical-To-Quality Dimensions. - Create, Review, and Approve Inspection Plans and Inspection tools as required. - Create and Support validations for new and existing products and processes, including packaging and sterilization. - Create and Support IQ, OQ, and PQ activities for equipment and additive implants. - Perform and support Gage Repeatability and Reproducibility (Gage R & R) studies. - Perform and support First Article Inspection / Inspections on Prototypes. - Perform Statistical rationales as required. - Support supplier quality management activities, including qualification, evaluation, and investigations. - Support Post Market Surveillance activities. - Support Complaint/NC/CAPA teams through the identification and development of corrective action plans, verification, and closure. - Perform and support Design and Process FMEA activities. - Collect, analyze, and summarize data and make recommendations as required. - Support and prepare for site-level internal, external, supplier, and customer audits. - Provide quality support to identify and resolve quality issues to ensure safe and effective medical devices. - Interact and coordinate activities with other departments, support, and customers. - Identify and implement opportunities for continuous improvement. - Create and update Quality System Procedures and Instructions when applicable. - Supports Quality, Engineering, and Regulatory to meet company and department objectives. - Other duties as assigned by management

Requirements

Engineering degree or equivalent and at least 8 years’ experience with mechanical inspection of precision machined products, medical device industry experience preferred. Excellent communication skills and the ability to work with people at all levels. Ability to work independently and in a team environment. Strong organizational skills, attention to detail, self-motivator, ability to multi-task and meet timelines. A working knowledge of desktop computer office software and e-mail is required. Understand calibration fundamentals. Experience using inspection equipment such as calipers, micrometers, height gauges, plug and ring thread gauges, and pin gauges. Optical comparator and Vision system experience preferred. Knowledge and understanding of Medical Device Regulations / Certifications such as 21CFR820 & ISO13485:2016. Medical Device experience is preferred.

Senior Quality Engineer

Description

Requirements

ChoiceSpine