Quality Engineer

We are looking for a quality engineer to monitor and improve the quality of our operational processes and outputs. The quality engineer's responsibilities include designing quality standards, inspecting materials, equipment, processes, and products, developing quality control systems, and determining corrective actions. You will also work with managers and supervisors to implement quality measures. A successful quality engineer should have excellent troubleshooting skills and be able to ensure that processes and products consistently meet established quality standards. Quality Engineer Responsibilities: u2022 Ensure design transfer activities comply with ISO 13485 and quality system requirements. u2022 Developing and implementing quality control systems. + Review and approve the translation of design input requirements into design output documents. u2022 Monitoring and analyzing quality performance. u2022 Inspecting and testing materials, equipment, processes, and products to ensure quality specifications are met. u2022 Collaborating with operations managers to develop and implement controls and improvements. u2022 Drive transfer readiness: FMEA, control plans, CTQs, first-article/PPAP evidence (as applicable). u2022 Investigating and troubleshooting product or production issues. u2022 Developing corrective actions, solutions, and improvements. u2022 Reviewing specifications, and processes. u2022 Managing non-conformances through MRB process. u2022 Participate in internal and external audits. Quality Engineer Requirements: u2022 Degree in quality, industrial, or mechanical engineering. u2022 Lean six sigma background preferred. u2022 Experience in fabrication and assembly processes preferred. u2022 Minimum of 3 years of experience in quality engineering, quality assurance, or a similar role. u2022 Experience with change control processes in a regulated environment. u2022 Strong communication and interpersonal skills. u2022 Strong analytical and problem-solving skills. Critical thinking, problem solving, reasoning, complex information processing u2022 Excellent project management skills. u2022 Knowledge of FDA, GMP, ISO 9001 and ISO 13485. u2022 Knowledge of PFMEA and PPAP processes.

Created: 2026-04-04