Supplier Quality Engineer.

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