Supplier Quality Specialist - Ballaigues, Switzerland (73702)
Dentsply Sirona, Bern
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Bringing out the best in people
As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we're looking for the best to join us.
Working at Dentsply Sirona you are able to:
Develop faster - with our commitment to the best professional development.
Perform better - as part of a high-performance, empowering culture.
Shape an industry - with a market leader that continues to drive innovation.
Make a difference -by helping improve oral health worldwide.
In this role you will perform the internal activity of Supplier Quality Management in close collaboration with quality assurance, purchasing, and R&D departments. You regularly monitor suppliers through non-conformity management process and you conducts supplier audits as per the supplier audit program's requirements.
Supplier Quality Specialist - Ballaigues, Switzerland
Qualification and validation of suppliers
* Lead the qualification of material and component suppliers in collaboration with R&D and the purchasing department.
* Lead the re-evaluation of the supplier in the event of a change in the supplier's scope of application.
* Monitor and maintain the qualification level of suppliers according to internal changes.
* Participates in the creation of First article inspection (FAI) plans.
* Lead the classification of suppliers in relation to the products or services provided.
* Regularly evaluates suppliers using specific quality criteria such as product compliance with purchase specifications, standards compliance, certifications, internal customer evaluations, etc.
Communication with suppliers
* Be the main point of contact for suppliers regarding quality issues.
* Work closely with suppliers to understand their manufacturing processes, quality practices, risk management policies and help them resolve quality issues.
Implementation of quality measures
* Defines quality metrics and key performance indicators to measure the quality of products or services provided by suppliers.
* Monitor trends and make requests to initiate improvement actions with the supplier or with internal incoming inspection.
* Participate to Quality hold evaluation and investigation (NC during incoming inspection).
* Develop action plans with the supplier to improve the quality of the products and services provided (SCAR).
Monitoring and reporting
* Maintains supplier quality records through Smartsolve (EDM software).
* Ensures the updating of the approved supplier list
* Lead the preparation of regular reports for the company's management on the quality performance of suppliers.
* Participates in the annual supplier audit program upon request and assists in resolving any non-conformity found with the supplier.
Requirements and Qualification
* Minimum bachelor degree level, ideally in the field of Medical Device Quality or mechanical
* Supplier or Internal auditor certification a plus
* Knowledge in standard 13485:2016 and 14971:2019
* Knowledge in applicable regulations of the MDSAP Program (a plus)
* Few years of experience in a QA department, in Medical device/Pharmaceutical, experience in supplier quality management is a plus
* Process Validation knowledge
* QA tools as KPI Dashboard
* Risk management approach
* Problem solving tools as, 5 Whys, Fishbone, 8D or other similar tools based on PDCA approach
* Statistical knowledge (inspection plan based on binomial or normal law)
* Language: French (min level C1), English (min C1 level)
* Ability to travel (max. 20%) in Europe only
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