Quality Engineer Job in Escondido 92029, California US

Quality Engineer – Medical Device

We are conducting a confidential search for a Medical Device Quality Engineer for a premier client in the Escondido, CA area.  This is an exciting opportunity to join an outstanding growth-oriented company offering  competitive base salary and benefits in addition to a great work environment.

This position has mandatory requirements.  If you meet the below requirements, we’d like to see your resume and discuss this opportunity with you.

1.       BS Degree required.  Advanced degree preferred.  Strongly  prefer ASQ Certified Quality Engineer or CQE. 

 

2.       Minimum 5-years medical device quality engineering with the bulk of this in electro-mechanical devices or medical instrumentation.  Strong laboratory and chemistry background is highly preferred.

 

3.    Demonstrated knowledge of FDA regulations, cGMPs, FMEA, DOE, CAPA, and Validation protocols IQ, OQ, and PQ.  Knowledge of statistics and statistical software packages such as Minitab.

 

4.    Ability to commute within 20-miles of the Escondido-San Marcos area.

 

Below is a sample job description.  An actual job description will be presented to highly qualified candidates.

Quality Engineer

Supports operations through application of Quality engineering skills for medical devices and services. This individual will play an active role in processes to ensure products and services meet quality standards consistent with company policies, while meeting all design control and other regulatory requirements.  This role also supports plant activities in process validation, process capability issues and customer issues, initiates corrective and preventive action, with an eye to increased capability and customer satisfaction and supports Quality System implementation.

 

• Participate in the development projects to help ensures products, services and processes are designed, developed and transferred to meet appropriate regulations and business outcomes

• Communicate significant issues or developments identified during quality activities and provides recommended process improvements to team or management.
• Leads and participates in CAPA teams in resolving production and customer issues. Dispositions any materials and components that are rejected for non-conformance with effective corrective and preventive actions
• Lead and participates in audits and assessment of the manufacturing operations, and recommends CAPA and process improvements.
• Apply and understand statistical methodologies, as appropriate, for conformity assessment and investigative activities.  Uses Minitab or other statistical analysis software to produce reports.

• Provides significant input to the quality system and maintains quality system policies.  Performs other related duties as assigned.

 

THIS IS AN URGENT SEARCH AND YOU ARE ENCOURAGED TO APPLY IMMEDIATELY IF INTERESTED AND QUALIFIED.  If you do not have an updated resume, please send us your old one, and give us a paragraph or two on what you have been doing most recently.

Hiring Authorities, Inc., is a global recruiting firm specializing in the Medical Device, Pharmaceutical, Biotechnology, and related industries.  We place multiple candidates each month at World Class companies.  More information on us may be viewed at WWW dot HIRINGAUTHORITIES dot COM or in MEDICAL DEVICE and DIAGNOSTIC INDUSTRY   MDDI magazine.  Follow Hiring Authorities, Inc. on Linkedin.com

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