Demant

Senior Quality Manager

Demant

full-time

Posted on:

Location Type: Office

Location: Middelfart • Denmark

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Job Level

Senior

About the role

  • Ensure all new product introductions and engineering change orders are supported by proper documentation and completed quality assurance activities before release to production.
  • Hold the authority to approve or reject design transfers to production.
  • Align and coordinate quality practices across Diagnostics production sites, ensuring products meet specifications and that supplier‑to‑shipment quality processes are followed.
  • Oversee execution of inspections in accordance with agreed inspection codes.
  • Maintain a strong connection between customer feedback and quality, ensuring complaints and major operational quality issues are communicated and addressed effectively.
  • Lead supplier quality assurance efforts and support purchasing in proactive initiatives.
  • Drive positive development of process KPIs and warranty‑related complaints within Operations.
  • Manage an effective CAPA process across all production sites.
  • Develop, update, and maintain QMS procedures related to Operations Quality.
  • Oversee departmental resources within company guidelines and managerial direction.
  • Develop and implement departmental strategies aligned with Diagnostics, Operations, and Global Quality & Regulatory objectives.

Requirements

  • Leadership experience in a global, multi‑stakeholder environment, ideally with teams or reports in different locations.
  • Minimum 5 years of experience in quality management; experience in the medical device industry is preferred.
  • Strong understanding of ISO 13485, MDR, FDA requirements, and global quality frameworks.
  • Demonstrated ability to assess risk and clearly communicate business impact.
  • Excellent analytical, documentation, and stakeholder‑management skills.
  • Fluency in English, written and spoken.
Benefits
  • A chance to join a team of experienced and passionate experts in the diagnostics business.
  • Responsibility for shaping and developing the local quality organization at different levels.
  • A role where you can truly make an impact by sharing your expertise, influencing decisions, and contributing to strategic initiatives and projects.
  • A dynamic and supportive environment with space for both personal and professional growth.
  • Flexible working hours that support your work–life balance.
  • A Scandinavian work culture built on equality, openness, independence, and informal communication.
  • An attractive compensation package and strong development opportunities.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality managementCAPA processQMS proceduresprocess KPIsrisk assessmentdocumentation
Soft Skills
leadershipstakeholder managementanalytical skillscommunication
Certifications
ISO 13485MDRFDA requirements