Job Description & How to Apply Below
The Quality Engineer proactively improves product quality through effective planning and proactively ensures effective implementation of resolutions to issues as they arise. This position shall provide support for Quality Management System to industry, customer and regulatory requirements. This position will provide a quality point of contract for our tier I customers and provide support and technical assistance and ensure customer requirements are adequately met.
Essential Duties and Responsibilities:
Ensure customer specifications are adequately communicated throughout the product realization cycle.
Communicate problems / Concerns to Customers and vendors.
Participate in Material Review Board (MRB) and Corrective and Preventive Action (CAPA) processing
Work closely with Sales, Customer Service, Production, Engineering and R&D to resolve quality issues, improve product and process quality
Quality & Cost Improvement Projects: Design and implement methods for process control, process improvement, testing and inspection
Support Cost of Quality implementation, and drive improvement initiatives to reduce overall cost of ownership.
Ensure the work in quality is completed according to expected delivery dates
Establish / Implement control plans that address all customers defined critical features
Monitor work in progress to ensure it is done according to customer specification
Work with engineering to make sure all quality specifications are properly defined
Assist with Advance Product Quality Planning (APQP): Develop Quality Plans for new productsIdentify and maintain key characteristics of partsAssess process capabilityIdentify and develop outsourced process quality requirements
Ensure FAI requirements are defined and met
Work with Engineering to develop FMEA for new product development
Required Education, Experience and Qualifications:
Bachelor's degree required; Engineering field highly desired. In lieu of engineering degree, ASQ certification required
5 years of quality experience required, preferably in a medical manufacturing environment
Ability to work cross functionally and coordinate the functionality across departments.
Proficiency in interpretation of specifications and engineering drawings including geometric dimensioning and tolerancing (GD&T) and ASME Y 14.5 requirements preferred experience with tight tolerances (± .0002”)
Intermediate to advanced SPC/Data analysis skills and proven ability to perform DOE, FMEA, ANOVA and Gage R&R analysis
Working Knowledge of the 21 CFR 820 QSR and ISO 13485:2016
Experience using standard quality tools i.e. Flow Charts, Pareto Charts, Histogram, Control Charts, Ishikawa Diagram, 5 Why's,
Experienced working in a CNC environment with multi axis machining
Must be able to communicate effectively with management, customers, suppliers and shop personnel
Experience using inspection equipment, such as micrometers, calipers, plug gages, and coordinate measuring machines (CMMs), etc
Licenses & Certifications
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