Quality Assurance Engineer

Duties & Responsibilities

• Support compliance of the QMS with 21 CFR Part 820, ISO 13485:2016, EU MDR, MDSAP, and other applicable regulatory requirements.
• Support the development, maintenance, and improvement of Standard Operating Procedures (SOPs), forms, templates, and other quality system documentation.
• Manage customer complaint investigations from intake through closure.
• Support investigation activities including root cause analysis, correction, containment and identification of corrective actions.
• Monitor complaint trends and recurring failure modes to identify opportunities for CAPA and product/process improvements.
• Support the administration and maintenance of the electronic CAPA system.
• Participate in CAPA Review Board activities and support the effective execution of the CAPA process.
• Review CAPA investigations and corrective/preventive action plans for completeness, accuracy, and timely execution.
• Monitor corrective and preventive actions and follow up with cross-functional teams to support timely completion and effectiveness.
• Support supplier quality activities including supplier qualification, performance monitoring, SCARs, incoming quality issues and ongoing supplier improvement.
• Assist with supplier changes and quality related change notifications.
• Support supplier audits and assessments, including preparation, follow-up and tracking of corrective actions to closure.
• Support validation activities for new and existing QMS software in compliance with 21 CFR Part 11.
• Assist in defining software validation requirements, specifications, and acceptance criteria for non-product software systems.
• Develop and execute validation deliverables, including test plans, test cases, and validation reports.
• Support internal and external audits and inspections, including FDA and notified body audits.
• Participate in internal quality audits and assist with the identification and resolution of audit findings.
• Track and report quality metrics, including nonconformances, CAPAs, audit findings, and complaints.
• Prepare quality reports, presentations, and other materials to support quality initiatives and management review.
• Collaborate with cross-functional teams to identify opportunities for process improvement and maintain QMS effectiveness.
• Other duties as needed or required.

Minimum Requirements & Qualifications

• Bachelor’s degree in Science, Engineering, or a related field.
• 1-3 years of experience in a highly regulated medical device or similarly regulated environment.
• Working knowledge of applicable regulations and standards, including 21 CFR Part 820, ISO 13485:2016, and 21 CFR Part 11.
• Familiarity with CAPA and customer complaint processes, quality systems, and internal audits.
• Experience or working knowledge of software validation or computerized system validation is preferred.
• Ability to work effectively on cross-functional projects and collaborate with teams across the organization.
• Strong analytical, organizational, planning, and problem-solving skills.
• Proficiency in Microsoft Office and familiarity with PLM and ERP systems.
• Ability to manage multiple priorities and work effectively in a fast-paced, deadline-driven, team-oriented environment.
• High attention to detail, organization, and accuracy.
• Strong verbal, written, and interpersonal communication skills.

Preferred Qualifications

• Experience in a medical device manufacturing environment.
• Familiarity with MDSAP, EU MDR, and FDA Quality System requirements.
• Experience with electronic QMS (eQMS) or quality management software.
• Experience supporting CAPA, Customer complaints, nonconformance, audit, or document control processes.
• Experience with validation of non-product software or computerized systems.