Quality Systems Engineer presso None

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.