Senior Engineer Complaint Handling - Custom Biotech Instruments

Roche

Company Type
Qualifications
Workhours

Switzerland, Zug, Rotkreuz

  • Job facts

The department “Case Investigation and Resolution” is a global Centre of Excellence for the resolution of customer product issues. It monitors effective resolution of global and local complaints and inquiries and ensures optimal levels of customer satisfaction and regulatory compliance. As a Senior Engineer you will be based in Rotkreuz, Switzerland and cover the following key responsibilities:

  • Support the clinical chemistry instrument team and act as single point of contact within the team and the necessary stakeholders regarding the Custom Biotech Instruments
  • Assuming full accountability for the management of cases (Inquiries & Complaints) according to regulatory and ISO Quality system requirements and needs of the Country Organizations in a timely manner
  • Resolving cases and performing correct processing and documentation for individual cases according to applied medical standards and quality system
  • Communicating evaluation/investigation results to Affiliates and other global interfaces
  • Collaborating with investigation teams to ensure an efficient approach for root cause analysis and with Business Area and global functions, and ensure appropriate measures from cases are derived
  • Who you are
    You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

    To be successful in this role, your qualifications include:

    • Academic degree in Biotechnology, Engineering or IT
    • Profound knowledge in the areas of Complaint Handling and In Vitro Diagnostics
    • Several years of experience in the development of diagnostic instruments and the product care of Custom Biotech Devices
    • Knowledge of varied regulatory requirements and quality practices, especially in the area of complaint management is a must (e.g., 21 CFR 820.198, ISO 10002, ISO 9001, ISO 13485)
    • Proficient skills in building up technical as well as business related reports and complaint statistics
    • Proven background with robust organization skills, problem solving, troubleshooting capabilities and ability to learn new systems and technologies
    • Strong customer service orientation, excellent communication skills and high sense of urgency to drive cases to a compliant and timely resolution
    • Capability to work independently and as part of a team
    • Fluent in English and German, both written and spoken – additional languages a plus
    Read more
  • Who we are
    Roche Diagnostics International Ltd in Rotkreuz is one of the world’s leading providers of diagnostic system solutions for clinics, laboratories and doctors’ offices. The company employs over 2200 people in Rotkreuz and is one of Roche Diagnostics’ main sites. Read more.

    Roche is an equal opportunity employer.
  • Job facts
    • Location Switzerland, Zug, Rotkreuz
    • Function Quality & Compliance
    • Subfunction Other Quality
    • Schedule Full-time
    • Job level Individual Contributor
    • Job type Regular Employee
    • Division Diagnostics
    • Posted since 2018/01/11
    • Job-ID 5005191922
  • Get in touch
    R. Portmann, Recruiting Specialist: +41 41 792 40 62
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To be successful in this role, your qualifications include:

  • Academic degree in Biotechnology, Engineering or IT
  • Profound knowledge in the areas of Complaint Handling and In Vitro Diagnostics
  • Several years of experience in the development of diagnostic instruments and the product care of Custom Biotech Devices
  • Knowledge of varied regulatory requirements and quality practices, especially in the area of complaint management is a must (e.g., 21 CFR 820.198, ISO 10002, ISO 9001, ISO 13485)
  • Proficient skills in building up technical as well as business related reports and complaint statistics
  • Proven background with robust organization skills, problem solving, troubleshooting capabilities and ability to learn new systems and technologies
  • Strong customer service orientation, excellent communication skills and high sense of urgency to drive cases to a compliant and timely resolution
  • Capability to work independently and as part of a team
  • Fluent in English and German, both written and spoken – additional languages a plus
  • Location Switzerland, Zug, Rotkreuz
  • Function Quality & Compliance
  • Subfunction Other Quality
  • Schedule Full-time
  • Job level Individual Contributor
  • Job type Regular Employee
  • Division Diagnostics
  • Posted since 2018/01/11
  • Job-ID 5005191922

Senior Engineer Complaint Handling – Custom Biotech Instruments

Quality Assurance Manager Operations

Intern in Complaint Handling

Read Full DescriptionHide Full Description
Confirmed 21 hours ago. Posted 30+ days ago.

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