Sterility & Cleanliness Assurance Engineer

Nobel Biocare AB; Karlskoga kommun; On-site; SEK 700,000 - 900,000; Full time

Job summary

Nobel Biocare AB in Karlskoga, Sweden, is seeking a highly capable Cleanliness & Sterility Assurance Engineer to support cleanliness, sterility, and regulatory compliance for dental implant manufacturing across Karlskoga and Yorba Linda sites.

You will lead validation studies, oversee process validations, and collaborate with Contamination Control and cross-functional teams to ensure high quality, safe medical devices and adherence to ISO 13485 and ISO 11137-1/2.

Qualifications

• Master's degree in a relevant scientific discipline.
• Minimum of 5 years of experience in medical device or regulated environments.
• Strong knowledge of contamination control and regulatory standards (ISO 13485, ISO 11137-1/2).

Responsibilities

• Define validation studies related to microbiological, physical, and chemical cleanliness for new equipment and modifications.
• Lead cleanliness process validations for new and updated manufacturing equipment.
• Develop and implement cleanliness monitoring activities with the Contamination Control Manager.
• Maintain and update contact material mapping and related documentation.
• Establish procedures, templates, and best practices for standardized cleanliness validation and monitoring.
• Support biological and microbiological safety strategies across the organization.
• Coordinate external testing with laboratories and vendors as required.
• Collaborate with cross-functional teams to drive continuous improvement and regulatory compliance.

Skills

Statistical analysis

Communication skills

Analytical mindset

Problem solving

Cross-functional collaboration

Education

Master's degree in Biotechnology, Biomedical Engineering, Microbiology, Toxicology, Biology, Chemistry, or related field

Job description

Nobel Biocare AB in Karlskoga, Sweden, is seeking a highly capable Cleanliness & Sterility Assurance Engineer to support cleanliness, sterility, and regulatory compliance for dental implant manufacturing across Karlskoga and Yorba Linda sites.

You will lead validation studies, oversee process validations, and collaborate with Contamination Control and cross-functional teams to ensure high quality, safe medical devices and adherence to ISO 13485 and ISO 11137-1/2.