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
- +41 58 201 55 50
- Basel Professionals IT & Life Sciences
