Quality Engineer -- San Antonio, TX

Arjo is seeking a Quality Engineer to ensure quality systems meet and exceed requirements of regulation bodies and corporate quality procedures. This role will use data analysis and engineering to ensure product quality and customer satisfaction.

The selected Quality professional will support Arjo’s Quality Systems, including, but not limited to CAPA, Non-Conformance, Internal Audits, Document Control, Training, and Complaints, Product Investigations. This support would include, but is not limited to, procedure creation/revision, process improvement, and facilitation of inter-department meetings, training, and documentation.

 Day-to-Day Activities:     

• Collaborate with internal stakeholders to drive formalization and implementation of management system plans.
• Take ownership of projects that integrate quality & regulatory with business objectives.
• Lead projects to improve effectiveness, efficiency, and company-wide understanding of Quality Systems.
• Serve as lead auditor and/or co-auditor for service center and corporate audits.
• Support Management Review preparation and speak to assigned task areas.
• Develop and maintain internal operating policies and procedures relating to regulatory and quality activities.
• Lead and direct North America Quality and Regulatory Compliance team in ad hoc projects. 

Qualifications:

• Bachelor degree in a STEM field required (other degrees will be considered if quality experience is relevant to the role); Master’s degree preferred.
• Must have 2+ years of prior experience in industry-related regulatory systems management.
• Thorough knowledge of applicable procedures and regulations of 21 CDR 803, 806, 820 FDA, Health Canada, ISO 13485/MDSAP.
• Excellent spreadsheet, database creation, and project management skills.
• Must have demonstrated presentation, facilitation skills and the ability to interact and communicate with senior management and Sales/Service/Field staff at all levels.
• ASQ CMQ/OE or CSQP preferred.
• Able to travel 15% (including international travel).

About Arjo

At Arjo, we believe that empowering movement within healthcare environments is essential to quality care. Our products and solutions are designed to promote a safe and dignified experience through patient handling, medical beds, personal hygiene, disinfection, diagnostics, and the prevention of pressure injuries and venous thromboembolism. With over 6500 people worldwide and 65 years caring for patients and healthcare professionals, we are committed to driving healthier outcomes for people facing mobility challenges.

For more information about Arjo visit www.arjo.com