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Supplier Quality Engineer

Michael Bailey Associates - UK Contracts

Posted on Mar 16, 2021 by Michael Bailey Associates - UK Contracts

Zuchwil, Solothurn, Switzerland
1 Apr 2021
Annual Salary

Title: Supplier Quality Engineer

Project Goal: To ensure all externally manufactured client products meet new EU MDR requirements.


* Become a working member of the technical file remediation efforts to ensure externally manufactured client 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:

o Manufacturing Process Information and Controls

o Production risk management file

o Validation protocols and reports

o 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 & 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.


Experience & Knowledge Preferred:

* Three years' experience as Supplier Quality engineer; Supplier Process Validation engineer; Project Engineer, Project Manager or equivalent role within regulated industry.

* Understanding supplier management and validation procedures and execution.

* Strong background in Medical Device Regulatory Compliance/Regulatory Affairs.

* 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.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Reference: 1129586427

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