Beschreibung
You are an Engineer with working experience in a Medical Device regulated environment? Your profession is your passion? You're a problem solver who is looking for a new challenge? Great!
Our client, an international pharmaceutical company, is looking for you!
Duration: 10 months
Location: Zuchwil
Project Goal:
To ensure all externally manufactured products meet new EU MDR requirements. Collaborate with suppliers to obtain details for manufacturing process information, production risk management and direct part marking. This information will be used to update the product's technical file to be in compliance with Medical Device Regulations. EU MDR SQE will work under the direction of the EU MDR SQ project supervisor.
Deliverables:
The EU MDR SQE will evaluate the supplier's manufacturing process information, production risk management, direct part marking documentation against MDR Requirements; collaborate with the supplier to revise existing or develop new manufacturing process information, production risk management and/or direct part marking documentation as applicable.
Scope of Work to include the following:
Become a working member of the technical file remediation efforts to ensure externally manufactured products meet EU MDR requirements. This includes supporting project deliverables; meeting project timelines; resolving identified supplier issues and executing the overall project related to technical file remediation requirements.
Assess supplier drawings and process information to support project deliverables:
- Manufacturing Process Information
- Production risk management file
- Validation protocols and reports
- Direct part marking documentation
- Work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information
- Cross coordinate Workstream activities/interdependencies with other workstream and project teams
- Partner with Supply Chain to support EU MDR supplier communications and rollout of EU MDR Supply Chain Workstream activities
- Support definition and clarification of EU MDR supplier related process requirements
- Support Review and Approval EU MDR Change Projects as applicable
- Support Supplier Quality Functional Impact Assessments as applicable
- Support Review and Approval of supplier Process Validation Protocols and Reports as applicable.
- Support the update of supplier related Inspection Criteria as applicable
Education and experience requirements:
- A minimum of a bachelor's degree or equivalent in engineering or associated technical field is required
- A minimum of 3 years' experience in a quality engineering is required
- A minimum of 2 years' experience in the medical device and/or pharmaceutical industry is required
- Familiarity with ISO 13485 and FDA QSR is required
- Excellent organizational skills and attention to detail is required
- Must be able to work independently and prioritize with limited supervision
- Strong written and oral communication and interpersonal (listening) skills
- Excellent computer, communication, and written skills are required
- Proficient in Microsoft Office suite is required
We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career.
If you are the person we're looking for please submit your application. We're looking forward to getting to know you.