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Complaint Handling Unit Manager - Medical Device - Lab Automation

We recruit for a confidential Medical Device client. Our client is a Global Player and has more than 80 years experience in the field of Lab Automation. Client's 60,000 associates serve customers in more than 125 countries and generated $16.5 billion of revenue in 2016. Client's systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use the life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs.

This challenging position is located in Munich:

Complaint Handling Unit Manager - Medical Device - Lab Automation

- Management of WITS Complaint Handling Unit (CHU) covering 5 different sites (location) and multiple WITS products);
- Oversee / Coordinate assignment of issues to various Complaint Analysts to assure that all complaints are investigated and closed according to requirements;
- Promote the knowledge on complaint Management and cooperate with WITS Risk Manager on the identifying & training of Complaint Analyst for issuing of PLRA´s;
- Managing the escalation of customer complaints associate to WITS products to MDR / MDV and/or FSCA;
- Maintaining KPI for the process of Complaint Handling within entire WITS organization;
- Maintaining & Generating occurrence trending of issues for all product families within WITS;
- Maintaining working network of SME from other departments (e.g. R&D, TechOps etc.) contributing to Complaint Investigation & Correction Process;
- Subject Mater Expert for Complaint Process during internal & external audits and/or inspections;
- Responsible for identifying probable risks and opportunities for improvement within Complaint Handling Process.

- A Bachelor’s degree or Master’s degree with 5+ years of experience, preferably in areas of life sciences, engineering, or quality assurance;
- Thorough knowledge and expertise in customer complaint management, ideally working experience in the IVD, medical devices or equivalent regulated environment;
- Strong knowledge of state-of-art regulation; demonstrated knowledge on adverse event and field action regulations (US, EU and Canada as minimum);
- Must be able to demonstrate skills in risk assessment (sFMEA) and root cause analysis;
- Excellence in the use of 5 Whys or other appropriate root cause investigation tool(s);
- Ability to work in matrix environment and lead interdisciplinary and cross-cultural team member; without direct reporting line;
- Ability to quickly establish credibility and trustworthiness with key stakeholders;
- Excellent command of verbal and written English;
- Goal oriented, interpersonal, self-motivated and team player.

If you are interested and qualified, please send us your resume as a Doc, RTF or PDF-File in English.
Kategorie Ingenieur Ansprechpartner BANDAO Unternehmensberatung GmbH
Markus Moser
Schloßbergstraße 1
D-82319 Starnberg
Tel. :+49-8151-555 1 666
Markus Moser
Branche Medical Device
Einsatzort München
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