Validation & Computerized Systems Engineer in Kloten, Switzerland at Nobel Biocare

Date Posted: 11/10/2018

Job Snapshot

Job Description

Job ID: NOB002530

About Us

Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single-tooth to fully edentulous indications. Nobel Biocare offers you a great place to work by giving you the opportunity to grow and be recognized for your effort and achievements.


Description

The Validation & Computerized Systems Engineer supports different projects with regard to Computerized Systems, Equipment Qualification, Process and Test Method Validation to ensure the appropriate execution of the projects as well as establishment of all required deliverables in accordance with internal and external requirements. Furthermore, incumbent for this position, needs to ensure that the Process Risk Management Procedure is followed by leading or participating in risk management meetings. Moreover, the incumbent for this position should deploy and utilize Statistical Process Control (SPC) where applicable and the holder of this position represents QA in IT Change Review Board to assure that software changes are conducted in accordance with internal as well as external requirements.

Main Responsibilities:

  • Support to improve the procedures for Computerized Systems, Process, test method validation, Process risk management and Equipment qualification to fullfil internal and external requirements
  • Participate in projects (mainly during design transfer and Launch preparation) as QA representative
  • Participate in process validation activities as support and QA representative
  • Support the training of users on the processes within the department and Process Engineers within Operations
  • Support as requested on Quality relevant activities (e.g. gap analysis due to changes in standards or regulations)
  • Lead the site responsibles with dotted lines, 20-30% travel required
  • Improve the procedures for process validation to fullfil internal and external requirements
  • Participate in projects (mainly during design transfer and Launch preparation) as QA representative
  • Participate in process validation activities as support and QA representative, review and approval of Validation protocols, reports and other related documentation
  • Evaluate and approve deviations related to validation protocols in order to guarantee documentation of incidents and identification of Corrective Action’s
  • Ensure validation documentation content is understandable and defendable during inspections
  • Answer to external authorities in audits of risk and validation area including backroom support
  • Train users of the processes within the department and Process Engineers within Operations
  • Participate in process validation activities as support and QA representative in multi-site initiatives to ensure harmonization across sites
  • Participate and approve Risk documentation (e.g. FMEA)
  • Approve Master Validation Plans
  • QA approval of re-qualification/re-validation activities and documentation
  • Participate in the Change Management process as reviewer/approver of associated Risk assessments
  • Manage the validation maintenance activities

Job Requirements



Qualifications

  • Engineering background in Life Science, prefferably Medical Device industry (e.g. higher education or technical education with at least 5 years relevant experience in a similar working environment).
  • Knowledge of the applicable standards such as ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 11 and other relevant regulations such as FDA guidelines and industry best practices (e.g. GAMP) is a must.
  • MDD Council Directive 93/42/EEC (EU MDR when established)
  • Working knowledge of statistics



Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

To be considered for this role, applicants must be either Swiss citizens, EU-nationals or have the legal right to live and work in Switzerland.

For agencies: please, note that we only accept direct applications. Submission of candidates from unsolicited third parties does not create any implied obligation on the part of Nobel Biocare/ Danaher group