Quality Systems Engineer

The Quality Systems Engineer plays a critical role in maintaining and improving the Quality Management System (QMS) in compliance with applicable regulatory requirements (e.g., ISO13485:2016, MDSAP, EU MDR 2017/745, QMSR FDA 21 CFR Part 820). This role is responsible for leading and managing Corrective and Preventive Actions (CAPAs), Internal and External Audits, Management Reviews, and Quality Plans.

The ideal candidate will possess a strong understanding of medical device regulations and quality system principles. Exceptional leadership and communication skills are essential for collaborating with cross-functional teams and fostering a culture of quality throughout the organization.

This role also involves maintaining, planning, coordinating, and implementing quality system processes and procedures to support the QMS. The Quality Systems Engineer will serve as the Subject Matter Expert (SME) for the company’s quality systems.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Ensures the Argen QMS complies with ISO13485, EU MDR, MDSAP, and U.S. Food and Drug Administration (FDA) regulations.
• Guides and maintains the CAPA process, including investigation, root cause analysis, corrective and preventive actions, and effectiveness verification, to drive continuous improvement and prevent recurrence of quality issues.
• Ensure timely closure and effectiveness verification of CAPAs.
• Monitor CAPA trends and report metrics to management.
• Plan, execute, and document internal audits to ensure compliance with quality standards, regulatory requirements, and QMS procedures.
• Coordinate and support external audits (e.g., FDA, Notified Bodies, customers).
• Track and facilitate closure of audit findings and observations.
• Plans, organizes, and facilitates management review meetings to evaluate the effectiveness of the QMS, review quality metrics, discuss improvement opportunities, and ensure appropriate resource allocation.
• Develop and manage quality plans for new products, process changes, and improvement initiatives.
• Collaborate with cross-functional teams to ensure quality objectives are met.
• Track progress and report on quality plan milestones and outcomes.
• Analyzes quality data and metrics to identify trends, monitor performance, and drive improvement initiatives, providing regular reports to management.
• Fosters a culture of quality throughout the organization by promoting awareness, accountability, and continuous improvement in quality processes and practices.
• Supports and participates in product recall activities including documentation, activity management, tracking and trending analysis, and interface with government officials, when applicable.
• Motivates and develops employees by providing feedback, training opportunities, and holding regular 1:1s.
• Delegates tasks, monitors progress and ensures alignment with departmental goals.
• Builds a culture of collaboration and accountability while actively resolving team conflicts.
• Other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Bachelor’s degree and a minimum of 5 years’ experience in the medical device industry or equivalent combination of education, training, and experience.
• Strong knowledge of FDA QMSR, ISO 13485, EU MDR, MDSAP and other applicable standards.
• 2 years auditing per ISO and/or FDA standards, including direct involvement with external regulatory audits.
• 5 years’ experience in managing CAPA processes, conducting investigations, performing root cause analysis, and implementing corrective and preventive actions.
• Internal Auditor Certification for ISO 13485 required.
• Lead Auditor Certification for ISO 13485 preferred but not needed.
• Demonstrated experience in planning and conducting internal and external audits.
• Excellent organizational and project management skills, with the ability to prioritize tasks, meet deadlines, and manage multiple projects simultaneously.
• Strong analytical and problem-solving skills, with the ability to analyze data, identify trends, and drive continuous improvement initiatives.
• Strong leadership and influencing skills, including the ability to set goals and follow through, build positive relationships.
• Team-oriented with good interpersonal skills who is hands-on with a high energy approach to work.
• Ability to communicate ideas and information clearly, effectively, and frequently (verbal and written).
• Ability to learn technical concepts by reading work instructions and standard operating procedures and completing on-the-job training.
• Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred.