Medical Device Quality Assurance Specialist
Há 2 dias
Coloplast is a leading medical device company with over 14,000 employees and products available in more than 143 countries.
We are looking for a Medical Device Quality Assurance Specialist to join our team at our new site in Portugal.
This role will play a key part in ensuring the quality of our products by partnering with process validation teams. The successful candidate will have a pivotal role in ensuring the success of our roll-out plan as process validation is a key compliance component and the gatekeeper for starting production at our new site.
The foundation of our products' quality lies in the validation of our processes, making this role critical to our users.
Key Responsibilities:
- Support and further the quality culture for the whole site
- Participate and lead validations on site
- Be the approver of validation and process validation related documentation
- Train, instruct and guide the organization on site within validation
- Support production – Partner towards production for validation and revalidation
- Identify and facilitate mitigation discussions for process risks
- Be the receiving end for Test Methods transfers; Coordination of validation activities across site
Minimum Requirements:
- A relevant academic background (B.Sc. or higher)
- Minimum 2 years as a Validation Engineer / Test Engineer or similar within a production environment
- Solid understanding within the field of Validation and Quality i.e. GDP and GMP etc. (Quality Assurance experience is a plus)
- Knowledge of process validation and process risk assessment
- Project knowledge and experience
- Holistic understanding of End-To-End production
- Fluent in spoken and written English (other languages are a plus)
This role offers a competitive salary and benefits package, including opportunities for professional development and advancement. Estimated salary range: €50,000 - €70,000 per annum based on location and experience.
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