**Job Description**
The Cleanliness and sterility assurance Engineer is responsible for supporting the cleanliness and sterility


assurance of medical devices for our dental implant manufacturing in Karlskoga (Sweden) and Yorba Linda (USA).


**Responsibilities**

- Define validation studies with respect to microbiological/physical/chemical Cleanliness for new equipment and equipment changes
- Perform cleanliness process validation of updated/new equipment
- Define cleanliness monitoring activities for updated/new equipment together with contamination control manager
- Maintain contact material mapping
- Build and maintain a framework of procedures and templates to ensure standard work for the cleanliness validation and monitoring activities.
- Support the biological and microbiological safety strategy
- Plan and coordinate external tests execution with approved vendors (at need).

**Job Requirements**

- Strong technical background (MSc or equivalent) in relevant field (Biotechnology or Biomedical Engineering, Microbiology, Toxicology, Biology, Chemistry or related science)
- 5 years of experience in MedTech industry or equivalent
- Solid knowledge of regulatory requirements and standards related to contamination control and cleanliness control or ability to rapidly develop expertise to function independently with minimal supervision (ISO 13485, ISO 11137-1&2)
- Solid understanding of manufacturing environment and process validation
- Solid expertise in statistical data analysis
- Fluent in English (spoken and written), Swedish is an asset.
- Excellent verbal & written communication skills
- Strong analytical skills

**Operating Company**
Nobel Biocare


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