Quality Assurance Engineer

Quality Engineer Position Summary We are seeking a detail-oriented Quality Engineer to support quality systems, manufacturing processes, and continuous improvement initiatives in a regulated environment. This role will play a key part in ensuring compliance with industry standards, supporting product quality, and driving operational excellence. Key Responsibilities Quality Systems & Compliance Ensure compliance with

ISO 13485, ISO 14971, FDA 21 CFR 820, EC GMP

, and other applicable regulatory requirements Support internal, external, customer, and regulatory audits , including preparation and follow-up activities Maintain and continuously improve quality procedures, work instructions, and documentation Manufacturing & Process Support Provide quality engineering support across molding, assembly, inspection, and packaging processes Lead process validations (IQ, OQ, PQ) and maintain validation documentation Participate in PFMEA, Control Plans, and risk management activities Support containment, investigation, and resolution of nonconformities Continuous Improvement Lead root cause investigations using tools such as 8D, Fishbone, and 5 Whys Implement and manage Corrective and Preventive Actions (CAPA) and verify effectiveness Drive continuous improvement initiatives using Lean and Six Sigma methodologies New Product Introduction (NPI) Support quality planning and risk assessments for new product development and transfers Review customer specifications, drawings, and validation requirements Ensure quality deliverables are completed to meet project timelines and milestones Supplier & Customer Quality Support supplier qualification, audits, and performance monitoring Investigate customer complaints and ensure timely, compliant resolution Collaborate with customers to improve quality and enhance satisfaction Required Qualifications Education Bachelor's degree in Engineering, Quality, Science, or a related field Experience 2-5+ years of quality engineering experience in a regulated manufacturing environment Preferred industries: medical device, pharmaceutical, or healthcare packaging Experience with molding or precision manufacturing processes is a plus Technical Skills Strong knowledge of:

ISO 13485 FDA 21 CFR 820 ISO 14971

risk management Process validation (IQ/OQ/PQ) Experience with statistical tools and SPC Proficiency in Microsoft Office ; experience with eQMS systems preferred Key Competencies Strong analytical and problem-solving skills High level of attention to detail and documentation accuracy Ability to work effectively in a cross-functional, fast-paced environment Clear and professional written and verbal communication skills Proven ability to manage multiple priorities and deadlines Preferred Certifications ASQ Certified Quality Engineer (CQE) Six Sigma Green Belt or higher

ISO 13485

Lead Auditor certification