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Quality Assurance Expert

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Sant Cugat del Vallès
Posted 10 hours ago
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Job Description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Roche Diagnostics empowers researchers and clinicians by providing one of the industry's most comprehensive testing portfolio of innovative diagnostic solutions, encompassing clinical chemistry and immunoassays to point of care testing and laboratory automation

Main tasks:

  • Acts as partner to the QFPs and applicable stakeholders to ensure completeness and appropriateness of IRM cases 

  • Tracks progress of actions and follows up with owners to ensure timely completion

  • Acts as a Subject Matter Expert for identified processes (ie: IRM, LoMo etc) 

  • Serves as a supportive coach for stakeholders, guiding them through the process so they become   autonomous (learning & development environment) 

  • Facilitates removal of bottlenecks (administrative or other) for the QFP Team to ensure timely execution

  • Supports internal and external audit readiness, where applicable

  • Partners with QFPs for data overviews/insights (ie: Management Review, stakeholder requests, etc)

  • Adopts the Risk Enabler in decision making

  • Assists Team members to prepare messages/presentations/meetings

  • Identifies continuous improvement opportunities across all customer areas and partners to identity and distill actions, data or insights

  • Escalates to QFPs when trends are identified 

  • Supports initiatives to enhance progress   


 

Additional tasks:

  • Promotes the effective sharing and retention of valuable knowledge and expertise

  • Fosters a culture of innovation and continuous improvement

  • Models behavior to support and enable new ways of working and a culture of continuous improvement

  • Embraces working in an "Agile" environment where solutions aren't always perfect from day one.

  • Proactive in learning, understanding and supporting colleagues

  • Builds strong relationships across different teams without having direct authority over them.

Qualifications of the position:


● Bachelor's degree in engineering, science, business administration or a related field and 3+ years experience
● Strong understanding of a Quality Management System 
● Knowledge and understanding of Quality and Regulatory requirements  (i.e. ISO 13485, FDA, GMP, others) 
● Able to organize and structure conversations - Project management skills
● Technical writing and data interpretation skills, including ability to focus on the right
degree of detail
● Strong communication, collaboration and facilitation skills

 

 

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.


Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

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