Quality Assurance Engineer

Position Summary:

As a key member of the Quality team, the Quality Assurance Engineer ensures the Quality Management System (QMS) complies with all applicable regulations and standards. This role is responsible for maintaining and enhancing the Corrective and Preventive Action (CAPA) system in collaboration with cross-functional teams, as well as leading validation activities for quality system software.

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.