Quality Engineer

Quality Engineer ARCH Medical Solutions - Philadelphia - 3.7 Philadelphia, PA Job Details 19 hours ago Qualifications Statistics Quality control statistical data analysis Corrective and preventive actions (CAPA) GMP Statistical analysis FDA regulations Measurement (quality control) Full Job Description Make an Impact in Quality & Innovation We are seeking a Quality Engineer to play a critical role in ensuring our products meet the highest standards of quality, reliability, and regulatory compliance. This position is a key technical resource , bridging engineering, manufacturing, and quality systems to support the delivery of high-performing medical products. If you are a detail-oriented problem solver with a passion for process improvement, risk mitigation, and regulatory excellence , this is an opportunity to contribute to meaningful, high-impact work. What You'll Do In this role, you will actively ensure that products, processes, and systems meet corporate, industry, and regulatory standards while driving continuous improvement. Key Responsibilities Ensure compliance with ISO 13485 and FDA quality system regulations Evaluate design and process changes for impact to Design History Files (DHF) and lead gap closure activities Develop and implement manufacturing control plans and supplier quality oversight Lead component qualification activities (first articles, capability studies, Gage

R&R, SPC

) Develop and validate inspection and test methods using advanced measurement tools (CMM, vision systems, micrometers, calipers) Conduct risk assessments (DFMEA / PFMEA) and support risk management initiatives Perform internal audits and participate in customer/regulatory audits Support CAPA investigations , nonconforming material processes, and root cause analysis Lead or support process validation and equipment qualification Drive continuous improvement initiatives across manufacturing and quality systems Support product transfers and design reviews , ensuring manufacturability and compliance What You Bring We are looking for a candidate who combines technical expertise, regulatory knowledge, and strong collaboration skills . Required Qualifications Bachelor's degree in Engineering or a related field Minimum 3 years of experience in an ISO-certified and/or FDA-regulated manufacturing environment Strong understanding of: Quality systems and methodologies FDA GMP and CAPA processes Statistical techniques and process control tools Preferred Qualifications Certified Quality Engineer (CQE) or equivalent Experience with GD&T (Geometric Dimensioning & Tolerancing) Background in design control and product development environments Core Competencies High level of accountability and self-motivation Strong analytical and problem-solving skills Effective communication and cross-functional collaboration Ability to interpret technical documentation and present findings clearly Why Join Us Be part of a high-impact quality team supporting regulated products Work in a collaborative environment focused on continuous improvement and innovation Opportunity to influence product quality, safety, and regulatory compliance Work Environment This role operates in a professional engineering and manufacturing setting with a moderate noise level. Occasional standing, walking, and interaction with production areas are required.