Cleanliness & Sterility Assurance Engineer

Are you passionate about quality, contamination control, and medical device manufacturing? We are looking for a Cleanliness & Sterility Assurance Engineer to join our team and support the cleanliness and sterility assurance of dental implant products manufactured at our sites in Karlskoga, Sweden, and Yorba Linda, USA.

In this role, you will play a key part in ensuring compliance with regulatory requirements and industry standards while contributing to the safety and quality of products that improve patients' lives worldwide.

Key Responsibilities

As a Cleanliness & Sterility Assurance Engineer, you will:

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

Qualifications and Experience

To succeed in this role, you should have:

A Master's degree (MSc) or equivalent in Biotechnology, Biomedical Engineering, Microbiology, Toxicology, Biology, Chemistry, or another relevant scientific discipline.
At least 5 years of experience within the Medical Device industry or a comparable regulated environment.
Strong knowledge of contamination control, cleanliness assurance, and applicable regulatory standards, or the ability to quickly develop expertise and work independently with limited supervision.
Experience with relevant standards such as ISO 13485 and ISO 11137-1 & 2.
A solid understanding of manufacturing processes and process validation methodologies.
Strong expertise in statistical analysis and interpretation of technical data.
Excellent communication skills, both written and verbal.
Fluency in English. Swedish language skills are considered an advantage.
A structured, analytical, and problem-solving mindset.