Quality Assurance Specialist
hace 2 días
Coloplast is a leading medical device company dedicated to improving the quality of life for people with intimate healthcare needs.
We develop products and services that cater to the specific needs of our customers, working closely with them to find innovative solutions. Our business includes Ostomy Care, Continence Care, Urology Care, and Wound and Skin Care.
Pursuing an ambitious growth agenda, we are constantly expanding our business and exploring new ways to move forward, always learning and looking for new opportunities.
Job DescriptionThe Quality Engineer plays a crucial role in ensuring compliance to external and internal quality requirements, supporting Operations value stream in accordance with Coloplast's Quality Management System.
Main Responsibilities:
- Create and maintain quality-related documentation, such as Device Master Record, Quality Plan, Control Plan, Quality Record, and local quality instructions.
- Ensure quality approval and release of products, handling non-conforming products, including control of returned goods and reporting in TrackWise, and handling lot status in E1.
- Handle CAPA (initiations, root cause investigations, and evaluation of effectiveness) and Quality-related change request tasks in projects through Change Control procedure.
- Distribute product drawings to production, support Head of Quality in data gathering for Quality Management Reviews, and participate in both internal and external audits.
- Implement, train, and follow up on continuous improvements, including participation in RCA, provide sparring and support to Global Operations, including Global Quality, and help improve overall quality understanding and support of Lean activities.
Requirements:
- Bachelor's degree in Chemical Engineering or relevant field.
- Minimum 3 years of experience within medical device manufacturing.
- Excellent knowledge of Quality Systems & Processes, Statistical Analysis & Tools, Technical Writing & Documentation, Regulatory Landscape, Standards & Regulations, System & Data Management, Validation, Design Control, Cross-Functional competencies, Business Understanding, Project Management, Self-Management/People Development, Decision-making, Collaboration, and Communication.
We are guided by three core values: Closeness, Passion, and Respect. We work closely with our customers to understand their needs, work passionately to create innovative products, and have deep respect for the private nature of the conditions our customers face.
We are committed to minimizing the trauma and taboo associated with these conditions, not only providing medical solutions but also advocating for patient dignity and well-being.
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