A Product Quality Engineer evaluates and tests products and manufacturing systems, to ensure that products are produced that meet quality and performance standards as well as safety and regulatory requirements. Develops product quality standards and monitors production and product testing.
$40 - $43 per hour (W2) We are seeking a "Quality Engineer" to join one of our leading healthcare clients. Position Summary The Quality Engineer, Regulatory Compliance will support quality system compliance activities to ensure adherence to applicable regulatory requirements, corporate quality standards, and internal procedures. The individual will partner with Quality, Manufacturing, Operations, and other cross-functional teams to drive compliance initiatives, support audits and inspections, manage quality records, and facilitate continuous improvement activities within the Quality Management System (QMS). Key Responsibilities Support compliance with FDA Quality System Regulations, QMSR, ISO 13485, and applicable corporate quality requirements. Conduct quality system assessments and compliance reviews to identify risks and improvement opportunities. Support internal, external, and regulatory audits and inspections. Review and approve quality records, including deviations, nonconformances, change controls, and CAPAs. Analyze quality and compliance metrics to identify trends and drive continuous improvement initiatives. Collaborate with cross-functional teams to ensure timely closure of quality system actions. Support implementation and maintenance of Quality Management System processes and procedures. Prepare quality and compliance reports, audit responses, and management review inputs. Assist with inspection readiness activities and regulatory commitments. Required Qualifications Bachelor's degree in Engineering, Quality, Life Sciences, or related technical discipline. 0-3 years of experience in Quality Engineering, Quality Systems, or Regulatory Compliance within a regulated industry. Strong analytical, problem-solving, and technical writing skills. Excellent communication and stakeholder management skills. Preferred Qualifications Medical device industry experience. Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification. Experience with electronic quality management systems (eQMS) Working knowledge of FDA regulations, Quality Management Systems, and
ISO 13485
requirements. Experience with CAPA, investigations, change management, nonconformance management, and risk assessment processes Experience supporting audits and regulatory inspections. Skills Quality Systems Compliance Audit Support Regulatory Compliance Data Analysis and Trending Risk Assessment Technical Documentation Continuous Improvement We are looking for the candidate who are eligible to work with any employers without sponsorship . If you're interested, please click "Apply" button.
