Senior Device Manufacturing Engineer (m/f)
Date: Feb 23, 2021
Location: Zagreb, HR, 10000
Company: Teva Pharmaceuticals
About us
Your responsibilities
- Serve as technical leader for third party device manufacturing, device investigation and implementation of process solutions
- Actively participate in creation and review of risk management documents
- Participate in IQ/OQ/PQ activities including the drafting or review of protocols and validation reports
- Oversee Process Failure Modes and Effects Analysis (pFMEA), and Design for Manufacture (DFM) and Design for Assembly (DFA) activities
- Participate in selection and qualification of device CMOs
- Work with project leaders and both internal and external team members to ensure proper DFx for commercialization of new products
- Review documents to support in-line products including change controls, manufacturing investigations, CAPA implementation plans and effectiveness checks
- Create process and equipment documentation for improvements and initial installation
Your profile
- Master’s Degree in science, engineering, or technical field
- Proven experience in the medical device and/or combination products field is mandatory
- Working experience of medical device GMP Quality Systems and related requirements
- Previous experience with drug devices (syringes, auto-injectors, nasal sprays, transdermal patches, inhalers)
- Medical device/combination product industrial and/or design control experience
- Previous experience supporting multi-site and multi-design device/combination product development teams along with Quality management system auditing experience is highly desirable
- Excellent interpersonal communication skills and the ability to navigate effectively within a cross-functional team environment
- Fluency in English is mandatory
- Readiness to travel if necessary
Place of work / Location
- Zagreb (Croatia), Sofia (Bulgaria), Ulm (Germany) or Haarlem/Amsterdam (Netherlands) - depending on your residence.
- Relocation support available
Reports To
Director, Third Party Operations EU
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