Supplier Quality Engineer II

Supplier Quality Engineer II

Duration - 7 Months, Contract, W-2

Location - Onsite in Irvine, CA

Pay - $42.50 to $50.70/hour

The Supplier Quality Engineer II will play a key role on critical projects leading successful part qualification efforts with external suppliers to support product development and commercial launch timelines. This position is cross-functional in nature and requires strong collaboration and partnership with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering and Receiving Inspection. The Supplier Quality Engineer II will work on-site in a very fast-paced and dynamic environment where being proactive and taking initiative are paramount to success.

Job Responsibilities:

* Facilitate/perform gage studies, process capability studies, and supplier process validations related to critical componentfeatures based on risks identified in FMEAs.

* Develop and validate test methods, which can encompass creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks.

* Create test method procedures and provide training. Provide engineering support to Receiving Inspection on component test methods and investigations.

* Support component specification development, identification of critical features, development of inspection methods and plans, test method validation,process validations and component capability assessments

* Supports risk management activities, including the development and implementation of FMEAs, process control plans, and quality agreements at suppliers

* Utilize statistical techniques and six sigma tools to analyze processes and drive continuous improvement activities

* Manage component investigations with suppliers and cross-functional partners

Skills:

* Knowledge and understanding of FDA's 21 CFR Part 820, ISO13485, ISO9001, and other International Regulatory Standards.

* Experience and/or proficient knowledge of Design Controls and test method development/validations.

* Experience with statistical techniques and tools such as Gage R&R, Statistical Process Control, or Process Capability Studies.

* Ability to conduct effective root cause analysis; driving non-conformance investigations; and assessment of corrective action strategies and effectiveness as applied through CAPAs.

* Knowledge of GD&T and ability to read and interpret drawings.

* Good understanding of process validations (IQ, OQ, PQ)

* Good understanding of manufacturing processes (i.e., injection molding, extrusion, machining, etc.).

* Good interpersonal skills, with the ability to negotiate and influence change.

* Possess the ability to multi-task, while maintaining high attention to detail

* Ability to achieve results in cross-functional team environment and build strong relationships with internal and external customers(suppliers)

Education/Experience:

* Bachelor's degree in engineering or scientific field

* At least 2 years of engineering experience in highly regulated industry (e.g. Med

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.