Quality Engineer I

Nissha Medical
paid time off, paid holidays, 401(k)
United States, Wisconsin, New Richmond
Mar 10, 2025
Founded in 1990 and based in New Richmond, WI, Isometric's vision was to manufacture tooling and provide manufacturing solutions to exacting specifications for ultra-small, ultra-precise, and ultra-complex applications. For the past 35 years, we're proud to say we've grown to be one of the largest medical-focused micro molders in the United States. In March 2024, Isometric was acquired by Nissha Medical Technologies (NMT), a global Contract Design/Development Manufacturing Organization. NMT's expertise in the design and development of endoscopic devices, combined with Isometric's market leading micro-molding capabilities, are revolutionizing drug delivery and medical devices including minimally invasive surgical instruments and surgical robotics. Together, we aim to meet the evolving needs of medical devices, enhance component miniaturization, and improve the maneuverability of small and precision components, ultimately contributing to improved device functionality. It's an exciting time to join our team, and we're hiring for a Quality Engineer I. This position contributes to project performance, verification of product/process conformance, and customer satisfaction by providing technical expertise and leadership in executing product assurance engineering activities throughout the project development lifecycle. This role also supports quality improvement activities and helps implement and maintain items within the Quality Management System (QMS). This is an exempt paid position, and the hours for this position are Monday-Friday, 7:00AM-3:30PM. Essential Functions and Responsibilities: Draft and document quality procedures, instructions, inspection methods, control plans, and other product-related documentation. Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues as needed. Participate in internal and external audits. Support customer audits. Work with customers to understand and align all quality requirements. Assist Material Review Board (MRB) to ensure timely disposition of products while ensuring corrective and preventative actions meet regulatory requirements. Support continuous improvement initiatives. Manage and investigate customer complaints, including Device History Record (DHR) reviews. Other duties as assigned. Education and/or Experience: Bachelor's degree or equivalent education/experience required. Minimum of 3 years of experience in the Medical Device Industry. Familiarity with Quality Systems and regulatory agencies, preferably ISO 13485 and FDA 21 CFR 820 Familiar with standard concepts, practices, and procedures within quality inspection. Computer proficiency in MS Word and ERP systems preferred Knowledge of clean room practices preferred Isometric offers a comprehensive benefit package along with competitive pay: 401(k) program with Company match available after 90 days 3 weeks of paid time off, 2 personal days, and 11 paid holidays (10 observed holidays + 1 floating holiday of your choice) Medical, Dental, and Vision options available the 1st of the month followed by your hire date. Health Savings Account options available including a quarterly company contribution Company paid coverages include Employee Life/AD&D & Short-Term Disability Voluntary benefit options include Long-Term Disability, Supplemental Life/AD&D for Employees, Spouse, and Children, Group Accident Insurance, Home Warranty coverage, Legal support coverage, and Pet insurance! Hands on training Isometric, a NMT Company, is an Equal Opportunity employer. We are committed to creating a diverse workforce; we support a work environment where colleagues are respected and given the opportunity to perform to their fullest potential. We consider all qualified applicants without regard to race, religion, color, sex, national origin, age, sexual orientation, gender identity, disability or veteran status, among other factors.