Supplier Quality Engineer job in Solothurn, Switzerland

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Contract

Discipline: Good Manufacturing Practice (GMP)

Location: Switzerland

This vacancy has now expired. Please see similar roles below...

An exciting opportunity has arisen for a Supplier Quality Engineer to collaborate with suppliers to obtain details for manufacturing process information, production risk management, process controls, validation and direct part marking. This is a contracted role in Switzerland, for a talented Quality Engineer.

Job Responsibilities

Become a working member of the technical file remediation efforts to ensure externally manufactured products meet EU MDR requirements.
Assess supplier drawings and process information to support project deliverables
Manufacturing Process Information and Controls
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.

Skills and 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 organisational skills and attention to detail is required. Must be able to work independently and prioritise 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.
Experience working with suppliers across multiple sites and franchises.
Ability to act as an SME in supplier business processes.
Experience with medical device technical files.

To Apply

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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