NPD Supplier Quality Engineering (Medical Products) Job at Ledgent Technology, Irvine, CA

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  • Ledgent Technology
  • Irvine, CA

Job Description

We are seeking a Supplier Quality Engineer to work on a team at our client site in Irvinve, CA.


The information below discusses the team responsibilities and job description. Please note: T est Method Development and ECR experience are a must. Solidworks skill - Ability to design at least medium level complexity fixtures.

Summary:

The main function of a supplier quality engineer is to research and test and develop quality standards for components. A typical quality engineer has the ability to read and interpret blueprints and evaluate component integrity and standards.

Job Responsibilities:

* Design inspection fixtures for Test Method Development using Solidworks.

* Write protocols and reports for Test Method Validation (Gage R &R ).

* Create and route complex ECR packages. Experience with Windchill PLM or similar change management software required.

* Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.

* Establishes program to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities.

* May write training material and conduct training sessions on quality control activities.

* May specialize in areas of quality control engineering, such as design, incoming material, process control, product evaluation, product reliability, inventory control, metrology, automated testing, software, research and development, and administrative application.

Skills:

* Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.

* Previous experience with computer applications and software related to engineering field, such as Solidworks.

Education/Experience:

* Bachelor's degree in engineering required.

* 8-10 years experience required

Team Notes:

NPD Supplier Quality Engineering Team. We support NPD programs with component qualification and RI inspection development activities.

o Does your team use any specific technology/software you want us to look out for? Yes, experience with Solidworks and Windchill PLM would be strongly preferred.

o What would standout for you in a resume? Experience in Test Method Development (Gage R&R), Inspection fixture design using solidworks, ECR package creation and history of complex project management.

o What does the ideal candidate need to possess to be successful in this role? Ability to work independently with minimal supervision. Be resourceful and have collaboration skills. Ability to figure out how to do things from Peers, cross-functional partners and based company procedure.

o What will a typical workday look like? Document creation and approval, Test method protocol and report writing, component inspection coordination, Fixture design using solidwork, communication with peers and cross functional team

o What will the work schedule be? Can any overtime be expected? How many days onsite? Standard hours (8-5). Overtime is unlikely, 5 days on-site. There could be flexibility on the hours and WFH for emergencies.

o Will you consider remote work? If yes, will they need to be in a specific time zone? No

o What are your top 3 required technical skills? Must haves? Solidworks, Test method development, Complex ECR experience.

o What are nice to have skills? Medical Device experience, NPD Quality Engineering, Project Management, Windchill experience



Desired Skills and Experience

new product development, supplier quality, medical products, components

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county , to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

Job Tags

Local area, Remote job,

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