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).
#LI-PG1
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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