Supplier Quality Engineer.

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We are currently seeking a Supplier Quality Engineer for one of our clients in Canton of Neuchatel.

If you are looking to work in a dynamic and very friendly working environment and in the medical devices sector then this is for you.

This is an open-ended temporary contract

 

Please note this vacancy requires fluency in French.

 

Your responsibilities:

  • Provides quality assurance leadership to select contract manufacturing sites and raw material suppliers engaged in the production of Integra products

  • Establishes and ensures the Approved Supplier List is up to date

  • Establishes timely planning and execution of supplier audits

  • Conducts Supplier Audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirements

  • Ensures comprehensive measurement systems in place to monitor supplier quality/reliability, and to identify, correct and prevent defects

  • Establish and ensure Supplier Quality Agreements are up to date for applicable suppliers engaged in the production of Integra products

  • Report on contract manufacturer performance metrics

  • Ensure technical support to QC, purchasing and production departments

  • Provide Quality Engineering Support to suppliers including audits/assessments, inspection technique support, verification /validation activities, CAPA and change management. FDA CFR part 820 and ISO 13485 regulations/standards will be the focus.

  • Addresses Supplier Change Requests in compliance with procedures and regulatory requirements.

  • Ensures that activities for validation of outsourced processes/products are performed and documented according to procedures and within the defined timeline.

  • Ensures that Supplier Non-conformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements.

  • Escalate supplier quality issues to management as appropriate, develop and propose robust and compliant solutions.

  • Participates in and leads continuous improvement projects and initiatives.

  • Participates and supports internal and third-party audits / inspections.

  • Manages or participates in quality projects as required.

  • Provides support with complaint investigations as required.


Your profile:

  • A minimum of a Bachelor’s Degree in an Engineering, Life Science, or a related technical discipline is required. Candidates with an equivalent combination of education and experience will also be considered for the position.

  • Experience working in a Medical Device manufacturing environment is preferred.

  • Operations supplier quality experience is preferred

  • Minimum 3 years of professional work experience in a GMP and /or ISO regulated

  • industry is required

  • Knowledge of Medical device standards and regulations such as ISO13485, 93/42

  • EEC, 21 CFR part 820

  • Auditing background is required

  • Lead Auditor certification to ISO 13485:2016 strongly preferred

  • Strong communication, teamwork, and organizational skills are essential

  • Strong analytical problem solving and root cause analysis skills

  • Use of ERP, PLM systems

  • Use of Microsoft office tools

  • Knowledge of statistical techniques

  • Experience or knowledge with the machining processes, injection molding, and/or electro-mechanical components/assembly is preferred

  • Willingness to travel as part of duties

  • Fluent in French and English




We are currently seeking a Supplier Quality Engineer for one of our clients in Canton of Neuchatel.

If you are looking to work in a dynamic and very friendly working environment and in the medical devices sector then this is for you.

This is an open-ended temporary contract

 

Please note this vacancy requires fluency in French.

 

Your responsibilities:

  • Provides quality assurance leadership to select contract manufacturing sites and raw material suppliers engaged in the production of Integra products

  • Establishes and ensures the Approved Supplier List is up to date

  • Establishes timely planning and execution of supplier audits

  • Conducts Supplier Audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirements

  • Ensures comprehensive measurement systems in place to monitor supplier quality/reliability, and to identify, correct and prevent defects

  • Establish and ensure Supplier Quality Agreements are up to date for applicable suppliers engaged in the production of Integra products

  • Report on contract manufacturer performance metrics

  • Ensure technical support to QC, purchasing and production departments

  • Provide Quality Engineering Support to suppliers including audits/assessments, inspection technique support, verification /validation activities, CAPA and change management. FDA CFR part 820 and ISO 13485 regulations/standards will be the focus.

  • Addresses Supplier Change Requests in compliance with procedures and regulatory requirements.

  • Ensures that activities for validation of outsourced processes/products are performed and documented according to procedures and within the defined timeline.

  • Ensures that Supplier Non-conformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements.

  • Escalate supplier quality issues to management as appropriate, develop and propose robust and compliant solutions.

  • Participates in and leads continuous improvement projects and initiatives.

  • Participates and supports internal and third-party audits / inspections.

  • Manages or participates in quality projects as required.

  • Provides support with complaint investigations as required.


Your profile:

  • A minimum of a Bachelor’s Degree in an Engineering, Life Science, or a related technical discipline is required. Candidates with an equivalent combination of education and experience will also be considered for the position.

  • Experience working in a Medical Device manufacturing environment is preferred.

  • Operations supplier quality experience is preferred

  • Minimum 3 years of professional work experience in a GMP and /or ISO regulated

  • industry is required

  • Knowledge of Medical device standards and regulations such as ISO13485, 93/42

  • EEC, 21 CFR part 820

  • Auditing background is required

  • Lead Auditor certification to ISO 13485:2016 strongly preferred

  • Strong communication, teamwork, and organizational skills are essential

  • Strong analytical problem solving and root cause analysis skills

  • Use of ERP, PLM systems

  • Use of Microsoft office tools

  • Knowledge of statistical techniques

  • Experience or knowledge with the machining processes, injection molding, and/or electro-mechanical components/assembly is preferred

  • Willingness to travel as part of duties

  • Fluent in French and English




contattaci.

saremo felici di rispondere alle tue domande in merito a questa posizione.

LN

Lucie Nasshan

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