Quality Engineers, Validation Consultant
A new job opportunity has arisen for an exciting Quality Engineer, Validation Consultant position to join an internationally known pharmaceutical organisation. ProClinical is advertising this position for an enthusiastic and hard-working individual to join this exciting company's office based in Switzerland. This is a contracted position.
The Quality Engineer, Validation Consultant will ensure that all externally manufactured products meet new EU Medical Device Regulation (EU MDR) requirements and will collaborate with suppliers to obtain deals for manufacturing process information, production risk management and direct part marking. This information will be used to update the products technical file to comply with Medical Device Regulations. The EU MDR Supplier Quality Engineer (SQE) will work under the direction of the EU MDR SQ project supervisor.
The EU MDR SQE will evaluate the suppliers manufacturing process information, production risk management, direct part marking documentation against MDR Requirements. They will also collaborate with the supplier to revise existing or develop new manufacturing process information, production risk management, and/or direct part marking documentation as applicable.
- Becoming a working member of the technical file remediation efforts. This will ensure that externally manufactured company products meet EU MDR requirements.
- Assessing supplier drawing and process information to support project deliverables.
- Working with suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information.
- Cross-coordinating Workstream activities/interdependencies with other workstream and project teams.
- Partnering with Supply Chain to support EU MDR supplier communications and rollout of EU MDR Supply Chain Workstream activities.
- Supporting, defining, and clarifying EU MDR supplier related process requirements.
- Supporting, reviewing, and approving EU MDR Change Projects as applicable.
- Supporting Supplier Quality Functional Impact Assessment as applicable.
- Supporting, reviewing and approving the supplier Process Validation Protocols and Reports as applicable.
- Supporting the update of supplier related Inspection Criteria as applicable.
Skills and Requirements:
- At least a bachelors degree in engineering, or an associated technical field. Equivalent experience will also be considered.
- A minimum of 3 years experience in quality engineering.
- A minimum of 2 years experience in the medical device and/or pharmaceutical industry.
- Familiarity with ISO 13485 and FDA QSR is required.
- Three years of experience as a Supply Quality engineer, Supplier Process Validation engineer, Project engineer, Project Manager or equivalent role within the regulated industry.
- Demonstrable understanding of supplier management and validation procedures, along with execution.
- An experienced background in Medical Device Regulatory Compliance/Regulatory Affairs.
- Demonstrable experience working with suppliers across multiple sites and franchises.
- Proven ability to act as an SME in supplier business processes.
- Experience with medical device technical files.
- Proficiency in Microsoft Office Suite.
- Excellent organisational skills; an ability to work independently and in a team.
- Confidence, self-reliance, and quick learning skills all desirable attributes.
- Good oral and written English communication and interpersonal skills.
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 Caleb Mensah on +44 203 854 1080 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.
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