Careers at ThermoFisher Scientific


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Job ID :
Location :
Germany - Germering
Job Description
Key Responsibilities:

  • Assist Quality Director in establishing, implementing, and maintaining the quality management system for the Software Organization.
  • Create (or review/update) QM/QA specific processes and perform trainings.
  • Manage tooling required to host QMS and execute or assist with other any other QM processes listed in QM System.
  • Assist other departments in ensuring QMS is up to date and relevant to business needs.
  • Support QM System harmonization including standardizing SDLC.
  • Assume ‘QA’ role in SDLC processes, conduct reviews and releases.
  • Host customer audits, ISO 9001 audits and conduct internal audits as well as conduct or assist with supplier audits.
  • Manage actions from all audits through to implementation and closure.
  • Support the functions to ensure that products and processes comply with the relevant requirement.
  • Preform root cause analysis and corrective action for process and product related non-conformances.
  • In a timely manner analyze failure and implement corrective and preventive action.
  • Drive (or assist with) process improvement activities such as PPI.

Minimum Qualifications (must have):

  • Working experience with IS0 9001 and basic knowledge of ISO 13485 (GxP regulations, GAMP5 and 21 CFR Part 11).
  • Good Experience in software development (requirement specification, code implementation and testing) as well as agile software development.
  • Computing skills including applications (MS Office, Visio, SVN, Jira, SharePoint, TFS, etc).
  • Experience of process design and improvement.
  • Ability to focus on continual improvement practices using causal analysis tools to drive corrective and preventive actions.
  • Be able to effectively communicate with customers as well as align with the internal function representatives (e.g. Customer Support, R&D and Marketing).
  • Excellent auditing capabilities and strong communication skills (both oral and written) will be necessary to support the assignment.
  • Must be a team player with strong interpersonal skills.
  • Ability to take direction quickly and continue to work with minimal supervision.
  • Up to 25% Travel (domestic and international).

Preferred Qualifications (nice to have):

  • Lead auditor training and certification preferred.
  • Several years working experience with ISO 13485.

Education & Experience:

  • Degree in computing, science or related discipline.
  • 3- 5 years Quality Assurance experience in a Pharmaceutical, Biological Sciences, Quality aware or related environment.
  • 5 – 10 years’ experience in SDLC.
  • Fluency in English and German (German minimum Level C1/C2).
  • Excellent oral and written communication skills.

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