ProClinical is working with a global Medical Device company based in United Kingdom who are looking to add to an existing R&D department. Our client has focus on designing medical devices that are distributed across the world. It is 12 months of contract.
- Support process and technology mapping related.
- Deliver mitigated risk assessment across business (PFMEA).
- Implement mitigations and assess control of the solutions.
- Organize and conduct system validations across business.
- Refine compliant distribution requirements.
- Change / Update procedures as required with other work streams.
- Prepare and execute system testing plan.
- Understand dependencies across work stream for change impact.
- Identify critical path and risks to project timeline.
- Issue status reports and effectively communicate to upper management.
- Work closely to support all testing.
- Update the full-scale End to End Business quality related flow and associated communication documents.
- Quantify the resources needed to achieve work stream project goals.
- Negotiate with other managers for the acquisition of required personnel from within the company to assess, prepare and perform all updates.
Skills and Requirements:
- University/Bachelor’s Degree or Equivalent in a Life Science, Engineering, or Physical Science discipline.
- Integrity around estimations and communications
- 5+ years of relevant experience.
- Fluent working in English. German or Italian are a plus.
- Project leadership experience.
- Previous proven Quality experience on large scale enterprises on medical devices requirements and compliance knowledge
- GMP, GDP, ISO 13485, CFR 820
- FMEA / Risk approach/ Mapping experience
- Operational Equipment qualification and/or CSV validation experience
- Excellent cultural awareness.
- Supply chain experience in medical device or pharmaceutical industry
- Influencing and managing others.
- Strong organization skills.
- Can drive continuous process improvements.
- Having the ability to work at both a macro and micro level as required.
- Ability to translate complex situations into simple working solutions.
- Proactive leadership approach with demonstrated skills in delivering major programs on time and within budget.
- Proficient user of MS Office, Excel, Word, PowerPoint, MS Project
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Ivan Gitardi on +44 203 0789 551 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.