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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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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