Quality Engineer

Job description

MAINPURPOSE OF JOB
 
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.
We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
Medtronic is a $27.8b company with 85,000+ employees in more than 160 countries.

JOB Summary
 
Reporting to Quality Engineering Supervisor

Act as Quality Engineer

Responsible for:
·  Supporting Quality Engineering activities related to new / improved / transferred manufacturing processes.
·  Conducting risk management activities: risk assessments on:
·  Manufacturing part of annual product review.
·  Proposed new processes.
·  Changes to existing processes.
·  New / revised materials.
·  Conducting validation
·  Conduct validations on new product / process / equipment.
·  Maintains validation status.
·  Ensuring GMP Compliance in area of responsibility (Medical devices, EU and FDA).
·  Providing support for resolution of technical issues (evaluation of potential consequences, determination of CAPA, etc).
·  Supporting the development and introduction of new products consistent with regulatory requirements for medical devices including change control process design and follow-up, documentation design and follow-up, and IT tools enhanced application for Quality support purpose.
·  Supporting the development and maintenance of Quality Engineering procedures.
Performing backup activities of the Quality Manager

MAIN JOB DUTIES/RESPONSIBILITIES

·  Ensures that documents are continuously reflecting the reality of business processes while complying with regulations, Corporate Policies and Spinal and Biologics Business requirements.
·  Provide support in implementing, keeping up to date and ensuring execution of the validation plan for equipments, processes, and automated and computerized systems.
·  Conducts validation activities (protocol, execution, report) including test method validation.
·  Assists R&D, Manufacturing Engineers and other Quality team members with validation and qualification studies and product testing activities.
·  Supports activities concerned with development, application, and maintenance of quality standards for industrials processes, materials and products.
·  Assists for CAPA  investigation, including non-conformities, recalls, complaints, audit results.
·  Responsible for ensuring that design phase of processes, equipment, and IT support applications match both anticipated business needs and user needs: from URS to detailed specification, with addressed partners and end-users.
·  Ensures that all equipments, processes and IT applications used for regulated activities are validated and maintained in the appropriate validation status.
·  Supports the design process review and complete risk management activities for products for which Kyphon Sàrl is legal manufacturer.
·  Participates to specific requirement adaptation for product design to meet regulatory compliance objectives (e.g. FDA, Japan…).
·  Respects the independence principle between design and validation.
·  Review and approval of validation documents,  change requests, maintenance / calibration documents
·  Ensures that all quality tools developed tend to paperless, accessible and user-friendly solutions (e.g. portal).
·  Performs others activities as required.

Desired profile

JOBQUALIFICATIONS
 
·  Ensures that documents are continuously reflecting the reality of business processes while complying with regulations, Corporate Policies and Spinal and Biologics Business requirements.
·  Provide support in implementing, keeping up to date and ensuring execution of the validation plan for equipments, processes, and automated and computerized systems.
·  Conducts validation activities (protocol, execution, report) including test method validation.
·  Assists R&D, Manufacturing Engineers and other Quality team members with validation and qualification studies and product testing activities.
·  Supports activities concerned with development, application, and maintenance of quality standards for industrials processes, materials and products.
·  Assists for CAPA  investigation, including non-conformities, recalls, complaints, audit results.
·  Responsible for ensuring that design phase of processes, equipment, and IT support applications match both anticipated business needs and user needs: from URS to detailed specification, with addressed partners and end-users.
·  Ensures that all equipments, processes and IT applications used for regulated activities are validated and maintained in the appropriate validation status.
·  Supports the design process review and complete risk management activities for products for which Kyphon Sàrl is legal manufacturer.
·  Participates to specific requirement adaptation for product design to meet regulatory compliance objectives (e.g. FDA, Japan…).
·  Respects the independence principle between design and validation.
·  Review and approval of validation documents,  change requests, maintenance / calibration documents
·  Ensures that all quality tools developed tend to paperless, accessible and user-friendly solutions (e.g. portal).
·  Performs others activities as required.
 

Languages
·  Good communication skills, both verbal and written of French and English.