Post-Market Complaint & Quality Lead (Temp)
Distalmotion
Mach aus dieser Rolle ein Vorstellungsgespräch — ein Lebenslauf und ein Anschreiben, die darauf ausgerichtet sind, was dieser Arbeitgeber sucht.
Benefits dieser Stelle
Zusammenfassung
Distalmotion is seeking a Complaint Handling & PMS Specialist to investigate product and customer complaints within the Quality & Regulatory team. This role drives the voice of the customer into product development and CAPA boards, influencing continuous improvement across Distalmotion products and services.
The successful candidate will lead cross-functional investigations of field-reported issues, manage complaint records, and collaborate with QA/RA, R&D, and service teams to ensure timely
Qualifikationen
- Significant knowledge of ISO-13485 and regulatory landscape (MDD, MDR).
- Experience in handling complaints is mandatory.
- Proven risk management experience per ISO 14971.
- Excellent communication to share quality and customer focus.
Aufgaben
- Own and improve the complaint handling process to ensure compliance and drive product improvement.
- Daily review of complaint data to evaluate reportability and escalate when needed.
- Coordinate with Clinical Specialist/Field Service for complete records and timely closure.
- Lead CAPA, R&D, PMO and training reviews related to complaints.
- Chair monthly Customer Complaint Board for management overview.
Kenntnisse
Ausbildung
Jobbeschreibung
Distalmotion is seeking a Complaint Handling & PMS Specialist to investigate product and customer complaints within the Quality & Regulatory team. This role drives the voice of the customer into product development and CAPA boards, influencing continuous improvement across Distalmotion products and services.
The successful candidate will lead cross-functional investigations of field-reported issues, manage complaint records, and collaborate with QA/RA, R&D, and service teams to ensure timely
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