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Quality Assurance Specialist
hace 2 meses
We are seeking a highly skilled Quality Assurance Specialist to join our team at ZimVie US Corp. As a key member of our quality team, you will be responsible for ensuring the quality of our products and processes.
Key Responsibilities- Guarantee quality compliance of processes and products associated with suppliers.
- Ensure that products are manufactured and delivered to ZimVie according to established quality standards.
- Select and coordinate the supplier lifecycle management, including initial selection and qualification, monitoring, and feedback.
- Manage the Supplier Production Process Approvals, including definition of control plans and process/product validations.
- Coordinate and execute the Supplier Corrective Actions Report.
- Carry out external audits and participate in internal audits of the Quality System.
- Support supplier validation activities of facilities, equipment, processes, and computer systems as established in internal procedures of the Quality System.
- Provide support in the management of Health Hazard Evaluations (HHE) and Health Hazard Evaluation Determination (HHED), Product Holds (internal/external), and product quarantines.
- Manage production transfer projects (Transfer vendor to vendor).
- Make modifications and updates to Biomet 3i Dental Ibérica documents as a result of the implementation of corporate procedures or other changes.
- Develop, modify, and implement Supplier Quality procedures, systems, processes, and metrics to drive standardization and common practices across the supplier network.
- Evaluate the conformity of dental purchased products manufactured in Biomet 3i Dental Ibérica when requested by the legal manufacturer.
- Manage New Product Introduction and/or new industrialization projects associated with suppliers.
- Participate or lead OPPs (Operating Project Plan) and improvement projects.
- Manage product and process non-conformities for purchased products.
- Manage measurement and control equipment out of specifications according to internal procedures.
- Select appropriate measuring equipment to carry out the inspection of the manufactured product.
- Write and execute TMVs (Test Method Validation).
- Prepare monthly indicators related to Supplier Quality activities.
- Manage incoming inspection sheets.
- Manage the Supplier Change Notifications.
- Be in possession of a university degree in Engineering or similar. Postgraduate degree in Quality Management or similar is desirable.
- Have at least 2-3 years of experience in a productive and multinational environment.
- Possess a high level of English, both spoken and written.
- Have knowledge in the use of office tools, especially Excel, as well as data analytics (Power BI). Furthermore, the use of ERP systems, especially Oracle, is essential.
- Knowledge of statistics associated with process control and sampling plans.
- Desirable to have knowledge about the operation of a Quality System and the international regulations applicable to the business sector, such as ISO 9001/13485 or 21 CFR 820 regulations.
- Competitive compensation package
- Permanent contract
- Meal allowance
- Partially remote work option available
- Private life, health, and dental insurance
- Learning & development program
