Quality and Validation Engineer

Quality and Validation Engineer


Validation and Quality Engineer Cepheid

Sökord: Validation, Quality Assurance Officer, QA



The Quality department at Cepheid is growing and is therefore looking for a Quality Engineer who will support the Technical Operations and Manufacturing management. As a Quality Engineer you will give support with QA related activities such as validations activities and support the document and monitoring of manufacturing deviations, and corrective actions. You will conduct audit of validation files, and participate in the daily management meetings.

Cepheid is expanding and in the beginning the role will be focusing on giving QA support to the set-up of new production lines. The Quality Engineer work closely with the validation specialist, quality department and manufacturing. As a Quality Engineer you are a supportive function, and it is of great importance that you are communicative, thorough and systematic.

To know more about Cepheid products, please visit: https://www.youtube.com/watch?v=mIsBLmjus6Q

Work responsibilities

• Exercises judgment within defined standards and procedures to determine appropriate actions
• Review documentation generated in Operations according to approved project plans
• Ensure the continuous implementation of the validation plans in the whole site
• Recommend changes and process improvements
• Approve validation document, deviations, CAPAs


Qualifications:

• University degree in engineering, science or equivalent.
• 1-2 years of process and manufacturing in quality assured operations
• Excellent skills in English and Swedish both in written and verbally
• Experience of validation and qualifications in manufacturing
Meritorious:

• Experience of ISO 13485
• GMP
To be success full in this role we think that you have personal attributes such as:

• High level of interpersonal skills
• Self-motivated with ability to own initiatives
• Problem solving skills
• Careful and thorough
• Ability to keep overview and keep focus
• Multi-tasking ability
• Systematic
Business: Cepheid

City: Solna

Employment: Open ended full time

Last date of application: 2018.01.25 Apply as soon as possible as we will assess candidates continuously.

For information: In this recruitment Cepheid is collaborating with Dfind Science & Engineering. For questions please contact responsible recruitment consultant Ellinor Crafoord 0733-434502. Apply via www.dfind.se/science-engineering as soon as possible.

Organization and Business description:

Cepheid is one of the fastest growing companies in molecular diagnostics. The company's unique diagnostic platform is used throughout the world, making a difference for patients as diagnosis and choice of treatment is facilitated by the test results. Cepheid offers a broad range of diagnostic products in virology, bacteriology and oncology that can meet tomorrow's demands for safe, fast and flexible diagnostic both in Western countries and in countries with limited resources. Globally, the company is represented by its headquarters in Sunnyvale, California, sales and marketing offices in Toulouse, France and technology and chemistry center in Bothell, Washington. Cepheid AB, part of the global Danaher group, is located in Solna, Sweden and has around 250 employees, mainly in production, quality control, research and development.

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