Quality Engineer

Quality Engineer – Medical Device Industry Job Summary We are seeking a skilled Quality Engineer with 4–5 years of experience in the Medical Device industry to support quality assurance and compliance activities within a regulated manufacturing environment. The ideal candidate will have hands‑on experience with FDA regulations, ISO standards, CAPA, investigations, and quality system processes supporting medical device manufacturing and product development. Key Responsibilities Support quality engineering activities for medical device manufacturing and product lifecycle processes Ensure compliance with FDA 21 CFR Part 820,

ISO 13485

, and applicable regulatory requirements Lead and support investigations related to deviations, non-conformances, complaints, CAPA, and root cause analysis Perform risk assessments and support risk management activities in accordance with ISO 14971 Review and approve quality documentation including SOPs, protocols, reports, work instructions, and engineering changes Support internal audits, supplier audits, and external regulatory inspections Collaborate with Manufacturing, R&D, Regulatory Affairs, and Supplier Quality teams to resolve quality issues Participate in validation activities including IQ/OQ/PQ, process validation, and test method validation (TMV) Monitor manufacturing trends and quality metrics to identify continuous improvement opportunities Support change control activities and ensure proper documentation within the Quality Management System (QMS) Assist with supplier quality management and incoming quality processes Ensure compliance with Good Documentation Practices (GDP) and data integrity requirements Required Qualifications Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, or related field 4–5 years of Quality Engineering experience in the Medical Device industry Strong knowledge of: FDA 21 CFR Part 820 ISO 13485

ISO 14971

CAPA and NCR processes Root Cause Analysis methodologies Experience working in GMP‑regulated manufacturing environments Hands‑on experience with validation documentation and protocol execution Strong understanding of Design Controls and Risk Management principles Experience using QMS systems such as TrackWise, ETQ, Veeva, MasterControl, or similar Excellent technical writing, communication, and problem‑solving skills Ability to work independently and within cross‑functional teams #J-18808-Ljbffr Novozen Healthcare LLC