Job ID R-361077
Date posted 23.06.2020BACK TO SEARCH RESULTSApply

Quality Engineer – Compliance

Job Description Summary

Job Description

Job Summary

The Quality Engineer Compliance position reports to the Associate Director Quality located in Eysins.  This position ensures compliance supporting BD WWISD and OUS MMS Pumps Businesses units and external Contract Manufacturers.

Duties and Responsibilities

The job holder’s duties or responsibilities are not limited to those listed below. The job holder is expected to perform other duties and responsibilities as assigned by the Associate Director Quality.

• Assists in establishing, implementing and maintaining the Quality Management System (QMS).

• Supports quality related projects for example implementation of new / revised standards such as FDA CFR820 and MDR, related to WWISD and OUS Pumps products where BD Eysins is the Legal Manufacturer or Distributor of Contract manufacturer products in the WWISD portfolio.


• Understanding of the requirements linked to the 5 MDSAP jurisdictions.


• Supports risk management file remediation for BD Eysins WWISD portfolio.


• Provides compliance support to BD Eysins related to FDA CFR820 MDSAP, ISO13485:2016 and ISO9001:2015 as well CE Certification.


• Supports projects by providing quality compliance input pertaining to Quality System pillars;


• Conduct supplier quality audits, including closing out audit findings, creating audit finding reports and determine proper corrective and preventive actions of contract manufacturers and suppliers under BD Eysins.


• Conducts internal quality audits, including closing out audit findings, creating audit finding reports and determine proper corrective and preventive actions.


• C2C administrator for Eysins Quality group.  Responsible for monthly monitoring and escalation as appropriate.


• QMS – implementation of SWIs and supporting documentation, translations, SharePoint and C2C notifications.


• Ability to liaise with different functions at multiple levels in the organization and drive for results.


• Good organization and communication skills. Structure thinking.


• Fluent in English.

Minimum Qualifications

These are only minimum qualifications for this position at this grade level. Other factors are taken into consideration when deciding what position and grade level to place an employee such as performance level, capable contribution level and company need. 

• Degree plus 5 years or more quality engineering / compliance experience within the medical technology industry or equivalent, or a combination of education and experience.


• Worked previously in a FDA regulated environment.

Specific Skills & Abilities

• Sound knowledge of US FDA 21 CFR 820 requirements, ISO 13485 / 9001 and Medical Device Directive 93/42/EEC requirements, MDR;


• Sound knowledge of MDSAP regulations;


• Knowledge of risk management;


• Good written and oral communication.


• Good prioritizing, organization, interpersonal, communication and analytical skills;


• Good computer skills (MS Office).


• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form;


• Ability to scope and manage projects.


• Ability to effectively present information to management.


• Ability to work autonomously and to appropriately prioritise workload independently.

Travel requirements

Limited travel is required for this role.

Primary Work Location

CHE Eysins - Business Park Terre-Bonne

Additional Locations

Work Shift

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