Quality and Regulatory

Job responsibilities:

• Manages applicable Quality processes and ensures process ownership for all activities under the QMS governance in scope.

• Ensures Document Control is established within scope, training profiles are assigned/enforced, all requirements are effective in all processes in scope and ensures compliant and effective QMS’s are maintained in scope.

• Business Process Expert role for Document Control processes and tools in scope.

• Establishes Document & Record support to authors and process owners in defining and producing compliant and lean Quality System documents and records; ensure proper quality of the content of documentation and records. Establishes and manages proper document review processes. Establishes, monitors, and responds to metrics on the efficacy and efficiency of the document management system and its ability to support the business.

• Leads and supports authors of controlled documents to be lean, well accessible, easy to maintain and according to the agreed look and feel.

• Collaboration with cross-functional teams across multiple work locations.

• General supporting QMS related work in audit, projects etc.

Skills:

• Bachelor’s degree or above in science or equivalent.

• Minimum of 3 years of similar work experience in the medical device industry or equivalent.

• Good understanding of ISO 13485 and other medical device standards and regulations.

• Excellent communication and interpersonal skills.

• Strong organizational and project management skills.

• Positive attitude and the will to take the lead for activities and projects. Can work under high pressure.

• Strong computer skills including Microsoft 365.

• Excellent communication skills in English is a must.