Allround Complaint Handling Specialist

Job Description:

The Complaint Handling department creates relevant data that leads to improvement to satisfy the customers’ needs.

The allround Complaint Handling specialist will evaluate each complaint on eligibility, reportability and need for investigation according to established processes following quality standards and applicable regulations.

When an investigation is considered necessary the allround Complaint Handling specialist will initiate and/or perform the investigation according to the working instructions established in order to confirm the complaint, determine the scope and find the root cause.

Information concerning an event that could be reportable or lead to a CAPA and/or Field Action will be forwarded to Competent Authorities, Notified Bodies, Manufacturing Sites, Quality Departments and/or Post Market Surveillance-teams.

Job Requirements:

Critical Knowledge and Qualifications: (what the role holder must know; including any required general or professional qualifications/education)

• Bachelor’s degree or equivalent work experience.
• Knowledge of quality standards within regulated industries.
• Experience in Good Documentation Practises or an equivalent qualification.

Critical Skills/technical know-how: (what the role holder must be able to do)

• Fluency in English, both spoken and written.
• Microsoft Office skills.
• SAP knowledge is a plus.

Critical Experience:

• 1+ years experience in a quality department in Medical Devices and/or other regulated industry.

Experience in Complaint Handling, Vigilance and/or Medical Device Reporting.

Operating Company:

Nobel Biocare

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