Senior Quality Assurance Specialist
hace 6 días
Coloplast is seeking an experienced Quality Assurance Specialist to join our team. As a key member of our Operations value stream, you will play a critical role in ensuring compliance with external and internal quality requirements.
Key Responsibilities:- Create and maintain quality-related documentation, including procedures and work instructions.
- Ensure quality approval and release of products, ensuring they meet our high standards.
- Handle non-conforming products, implementing corrective actions as necessary.
- Distribute product drawings to production teams, facilitating efficient manufacturing processes.
- Support Head of Quality in data gathering for Quality Management Reviews, driving continuous improvement.
- Implement new machines and item transfers, ensuring seamless integration into our operations.
- Participate in both internal and external audits, demonstrating our commitment to quality excellence.
- Bachelor's degree in Industrial Engineering, Quality, Production, Chemistry, or equivalent.
- Minimum 2 years of experience in medical device or manufacturing industry.
- Minimum 3 years of experience in Quality-related roles.
- Knowledge of statistical/data analysis and report writing experience.
- Experience with control of nonconforming material and corrective actions.
- Experience with Microsoft Office package and quality management software.
- English (minimum B1 level) reading, writing, and speaking skills.
- Quality Systems & Processes
- Statistical Analysis & Tools
- Technical Writing & Documentation
- System & Data Management
- Validation
- Design Control
- Cross Functional competencies:
- Business Understanding
- Project Management
- Self-Management / People Development
- Decision-making
- Collaboration
- Communication
We develop and market products and services that make life easier for people with intimate healthcare needs. As one of the world's leading medical device companies, we employ approximately 16,000 people and have products available in over 143 countries.
Salary Range:The estimated salary for this position is $90,000 - $120,000 per annum, depending on location and experience.
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