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Quality Engineer II - Exempt

$97k+
Estimation
Full-time
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Must Have:
10. Computer literacy in MS Word, Excel, PowerPoint
Ability to understand Supplier Change Control process
• Ability to use statistical techniques to analyze data
• Collaborates with product development teams to support new product development or existing product line extensions/modifications by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yields. Communicates with senior internal groups and frequent interaction with external groups (i.e. vendors, suppliers, etc.).
data acquisition & analysis - minitab
Demonstrated understanding of data protection practices, risk management processes, cybersecurity principles, and incident response methodologies
Experience in extrusion or molding processes
· Knowledge and experience with fabrication processes including molding, stamping and casting
Quality Engineering
Supplier Quality

Nice to Have:
basic statistical analysis
• Collaborates with cross functional engineering teams to support product line extensions/modifications by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yields. Communicates with senior internal groups and frequent interaction with external groups (i.e. vendors, suppliers, etc.).

JOB DESCRIPTION
JOB DESCRIPTION: Quality Engineer II:
Provide Quality Technical support for Release Product Engineering (RPE) and New Product Development (NPD) related projects and deliverables.
Engineer will have responsibilities in supporting continuous change control processes for various device families and production sites leveraging quality engineering knowledge to guide and drive for compliance.
Provide engineering expertise for plant sites and manufacturing change requests through providing knowledge and guidance on change orders related to supplier manufacturing processes, plant device assembly manufacturing processes, component tooling and qualification processes, tooling and assembly process validations and verifications, as well as design change control processes and risk management analysis, understanding of failure modes and risk analysis, process controls.
Engineer will have responsibilities in supporting Medical Devices manufactured at various *** manufacturing sites in the capacity as Quality Engineer II.
Engineer will have responsibilities in supporting in capacity as supplier quality engineering (interfacing with suppliers, plant engineering, cross-functional teams of sourcing / buyer / planner, materials engineers, and design engineers, in the capacity of providing expertise and support in qualification of component and tooling processes for plastic or metal components, and occasionally electrical component processes. This requires skillset of statistical knowledge and tools as well as component manufacturing process and process FMEAs, Control Plans, and validations of respective plastic and metal tools and machines.
Engineer will have responsibilities in supporting Medical Devices in New Product Development (NPD) in the capacity of extended quality support for pre-launch design qualification and deliverables such as component qualification processes, risk management where applicable, and manufacturing assembly line validation and verification processes, along with facilitating failure modes and affects analysis in design and process capacity with cross-functional teams for design verification and validation.
Engineer will have responsibility in supporting Medical devices in New Product Development in capacity of engineering support for test method validations for design evaluation nd implementation for design verification and validation.
Top 3 technical skills that are required for this role:
Quality Skills pertaining to Statistical Analysis, Production Part approval and Qualification Processes, Capability Analysis, Measurement System Analysis, Component Metals or Plastic Manufacturing Processes and Tooling Qualification
Risk Management Analysis, Failure Modes and Effects Analysis (FMEAs),
Design Change Control Processes, GD&T Knowledge
Microsoft Office Applications, Minitab Statistical Analysis Application (or similar),
Education Required:
Bachelors degree required
Years’ Experience Required:
Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Will the contractor be working 40 hours a week? If not, weekly estimate? – YES 40 Hrs / Week
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? – YES ONSITE, HYBRID – 2 Days Remote, 3 Days In Person
What is your timeline for scheduling interviews? - IMMEDIATE
What product line will this person support? – VARIOUS specific to Surgical Business Unit (Surgical OU) – General Surgical Technologies (GST) IOU – Product Portfolio – Access & Instrumentation Devices

Quality Engineer / Reliability Engineer:
Quality Engineering Expertise Support for Release Product Engineering as well as New Product Engineering.
Engineer will have responsibilites in supporting and leading Release product engineering support for devices in the field to navigate continuous change control processes and requests from various manufacturing plant sites and driving engineering expertise to challenge and drive proper change control in place for requested changes from tooling, capacity, validations, design changes.
Engineer will have responsibilities in supporting Medical Devices Manufactured at various *** Manufacturing sites in the capacity as Supplier Quality Engineer (interfacing with suppliers, plant engineering, cross-functional teams of sourcing/buyer/planner, and materials engineers, and design engineers, in the capacity of providing expertise and support in qualification of component and tooling proceses for plastic or metal components, and sometimes electrical) requiring skillset of statistical knowledge and tools as well as component manufacturing processes and process fmeas, control plans, and validations of those tools.
Engineer will have responsibilities in supporting Medical Devices in New Product Development in the capacity of extended quality support for pre-launch designs and similar component qualification processes, risk management where applicable, and assembly line manufacturing and validation processes, along with facilitating and driving design FMEAS, or Process FMEAs with cross-funcitonal teams for device design and manufacturing processes.
Engineer will have responsibilities in supporting Medical Devices in New Product Development in the capacity of engineering support for test method validations for design evaluation and implementation for design verification and validation. •

Last updated on Nov 22, 2023

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