Supplier Quality Engineer II- Spiddal Galway

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By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers' success Innovation We create better solutions Collaboration We create success together Inclusion We always interact with others respectfully Candor We are open and honest with one another Integrity We do the right things and do things right What you'll do in this role: The primary purpose of this position is to perform work which involves general engineering methods and tools. You will now be utilizing more advanced quality tools and concepts while developing your role as a quality engineer in the medical device industry. You apply engineering concepts to resolve acute or chronic problems. You will ensure Integer internal and external customer expectations are met or exceeded with the direction, instruction and guidance from more experienced engineers and managers in your organization. You adhere to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements. Specific Supplier Quality responsibilities: You will manage supplier non-conformances, liaising with suppliers to ensure all issues are adequately addressed You will manage and conduct supplier audits, tracking the closure of any audit related findings. You will lead the suppliers' product and process change notification system, as applicable You will lead Supplier Quality Agreement management process with suppliers. You will work with Suppliers, Management, Supply Chain, Engineers and Manufacturing associates in the resolution of supplier quality problems. Also, assist each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc. You will be responsible for managing the sourced item qualification process and ensuring all appropriate documentation is completed. You will be responsible for managing the First Article Inspection process. You will monitor supplier related KPIs, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained. You will review the adequacy and correctness of changes to Bill of Materials (BOM's), Incoming Inspection Plans, Drawings, Component Specification, FMEAs, etc. You will be supplier quality resource for any site continuous improvement projects. You will support product transfers. You may provide supervision for up to 3 engineering direct reports. As well, you will serve as a coach and mentor for other engineers, modeling the behaviors and disciplines of an engineering or technical professional. You will perform work on technical projects where you will follow Integer's standard quality management and production system methodologies to investigate opportunities for product and process improvements. You are expected to collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as an engineer. Support Non-Conforming Material Process: You will ensure that the disposition of supplier caused non-conforming materials meet all necessary procedures and assure adequacy of supplier corrective actions to prevent re-occurrence. You will lead site SCAR activities, including analysis of data and trends in supplier quality nonconforming material, bounding and containment, root cause analysis and effectiveness verification. Support Site Quality Activities: You will support and lead internal quality audit activities, as applicable You will support regulatory and agency inspections, audits, investigations, and inquiries related to supplier quality. You embed Quality- "I own Quality." You are a standard bearer for Quality in everything we do at Integer, by assuring adherence to our Quality Management System (QMS), supporting to corrective and preventive actions investigation and implementation, and contributing to the successful attainment of our quality KPI's and journey to 5 Sigma. You may perform other duties as needed and as directed by your line of supervision. Support Integer's Manufacturing Excellence and Market Focused Innovation Strategies Strategy Alignment through Site Hoshin Plans, Quality Plans, Validation master plans, associated quality improvement imperatives, and regular updates to QA RA weekly and monthly metrics, supporting the walk to 5 sigma. Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required. Standardization through wor

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