Quality Systems Engineer IIApply
Locations: New Ross, Ireland
Time Type: Full time
Posted on: Posted 2 Days Ago
Job Requisition ID: R29228
By living according to a common set of values, we create a culture that unifies and embraces the uniqueness we all bring to the company, positioning 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.Who are we? Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs (original equipment manufacturers) to enhance the lives of patients worldwide and a provider of high-end niche batteries for specialized applications in the energy, military, and environmental markets. We are guided by our six values and are part of a team passionately pursuing excellence in all that we do.
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 utilize advanced quality tools and concepts while developing your role as a quality engineer in the medical device industry. You will apply engineering concepts to resolve acute or chronic problems and ensure that Integer internal and external customer expectations are met or exceeded with guidance from experienced engineers and managers.
You will adhere to Integer's Values and all safety, environmental, security, and quality requirements, including Quality Management Systems (QMS), FDA regulations, and other regulatory requirements.Manufacturing Support: You will support regulatory inspections, audits, and inquiries regarding product design and manufacturing quality.You will monitor manufacturing of assigned products, assuring compliance with DMR and maintaining complete and correct Device History Records.You will review changes to Bill of Materials (BOMs), Assembly Procedures, Drawings, Component Specifications, FMEAs, Control Plans, etc.You will participate in continuous improvement projects.You will assist with product transfers.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, ask questions, and check for understanding in support of your development as an engineer.Support Non-Conforming Material Process: You will ensure that the disposition of non-conforming materials meets all necessary procedures and assure adequacy of corrective actions to prevent re-occurrence.You will lead and manage complaint investigations.You will participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, and root cause analysis.You will apply standard data analysis practices to establish root cause for product and process failures.Support Site Quality Activities: You will support internal quality audit activities, as applicable.You will assure adherence to our Quality Management System (QMS) and contribute to the successful attainment of our quality KPIs.You may perform other duties as needed and directed by your line of supervision.Support Integer's Manufacturing Excellence and Market Focused Innovation Strategies: Align strategy through Site Hoshin Plans, Quality Plans, and regular updates to QA RA metrics.Ensure customer change notifications are initiated and completed as necessary.Promote standardization through workplace organization and robust training programs.Engage associates through standardized problem-solving methodologies.Optimize systems and processes through built-in-quality principles.U.S. Applicants: EOE/AA Disability/Veteran
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