Quality Engineer I

Role Overview

Support all Quality activities of a high-volume hydrophobic coating plant, including MRB support, CAPA management, complaint investigation, audit support, change management, NPI activities, and continuous improvement.

As an entry level engineer, you will ensure that Integer's internal and external customer expectations are met or exceeded with the direction, instruction and guidance from more experienced engineers and managers in your organization.

Manufacturing Support

• Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
• Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
• Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
• Participate in continuous improvement projects.
• Assist with product transfers.
• Perform work on technical projects following Integer's standard quality management and production system methodologies to investigate opportunities for product and process improvements.
• Collaborate with others in the exchange of information, ask questions and regularly check for understanding in support of your development as an engineer.

Create Test Methods

• Support generation and completion of protocols and reports for test method validations.
• Interface with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies.
• Recommend process monitoring devices where applicable.
• Develop various inspection techniques and procedures to ensure product integrity to design specifications.
• Responsible for the writing, approval, and implementation of Incoming, In-Process and Final Inspection procedures.

Support Non-Conforming Material Process

• Ensure that the disposition of non-conforming materials meet all necessary procedures and assure adequacy of corrective actions to prevent re-occurrence.
• Lead and manage complaint investigations.
• Participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
• Apply standard data analysis practices and observe products and processes to establish root cause for product and process failures or to support the justification for improvements to products and processes.

Support Site Quality Activities

• Support internal quality audit activities, as applicable.
• Embed Quality - "I own Quality." Be a standard bearer for Quality by assuring adherence to the Quality Management System (QMS), supporting corrective and preventive actions investigation and implementation, and contributing to the successful attainment of quality KPI's and journey to differentiated quality.
• Perform other duties as needed and as directed by line of supervision.

Support 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.
• Leadership of Sustained Change ensuring customer change notifications are initiated and completed, as necessary, and supporting continuous improvement activities as required.
• Standardization through workplace organization & visual controls (5S), Manufacturing Standard Work, and robust training & certification programs where applicable.
• Associate Engagement promoted through the adoption of standardized problem solving methodologies, behavior-based safety programs, and improvement idea and suggestion systems.
• Systems & Process Optimization through adoption of principles of built-in-quality.