Quality Assurance Engineer

Summary

The Quality Assurance Engineer (QAE) manages the companies integrated quality management system which includes certification to AS9100, ISO 13485, ISO 14001 standards. The QAE monitors and audits the quality of all manufactured goods using tools defined by the QMS, the EPR system and process work instructions/methods. Additionally, the QAE supports testing and inspecting products to make sure they meet specified standards and supports process engineering to determine the quality of processes, and improve product quality.

This position will be working on-site at our facility located in Carlsbad, CA

Essential Functions

• Manage internal audits and address nonconformities from internal and external audits.

• Prepare for and participate in quality system audits for AS9100, ISO 13485, ISO 14001 as well as customer audits

• Lead problem-solving efforts, including customer complaint investigation and analysis to identify and resolve quality issues and maintain tracking system 

• Review and approve program non-conformances (NC) & material review board (MRB) dispositions.

• Review customer contract documents (e.g. contractual documents, purchase orders, statements of work, attachments, specifications, etc.) then work with program management and process engineering to ensure such flow down requirements are included in sale order and process methods in order to ensure conforming shipments.

• Assist Process Engineering to develop and release inspection criteria and standards as applicable to ensure product is built to customer requirements

• Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.

• Lead quality assurance’s role in the Material Review Board (MRB) process.

• Work in with the procurement department to flow down quality requirements to suppliers

• Initiate corrective/preventive action activities for nonconforming product including investigation, follow-up and root cause analysis. Manage all CAPA activity for timely completion for assigned work centers.

• Assist in planning for and presenting at the Quarterly Management Review meeting.

• Administer the Electrostatic Discharge (ESD) and Foreign Object Debris (FOD) programs.

• Responsible for the processing of ‘reason codes’ in the ERP system and then into the company’s SQC/SPC requirements.

• Promote and complete 6-S and Kaizen training and events

Education, Experience, and Skills

• Bachelor’s degree or equivalent experience and ASQ certifications desired

• Minimum of 5 years of experience in quality assurance functions. Minimum of three years’ experience in a contract manufacturing background preferred.

• Previous experience with and understanding of ISO9001, AS9100, ISO13485, ISO14001, AS9102, and FAR – DFAR documentation

• Familiarity with quality testing tools and procedures required. Familiarity with IPC 600, IPC 610, and IPC 620 and JSTD-001 preferred

• Strong English communication skills. Must be able to create and write clear and detailed records and documents.

• Strong computer skills including Microsoft Office and must be able to perform assigned duties within the ERP system.

• Ability to work independently, stay focused, and perform in a fast-paced and deadline driven environment

• Good analytical and problem solving skills, as well as a keen attention to detail

• Strong interpersonal and teamwork skills are necessary to enable individual to work with all positions and personalities

• Able to read and interpret prints and drawings.

Salary Range: $90,000 - $120,000 annual

About MEI 

• We are a successful, growing contract design and manufacturing company located in the Carlsbad Research Center

• We are a mid-size company (70 employees) with a small company “family” feel

• We serve the semiconductor, medical, aerospace, and defense industries; our customers are industry leaders in their fields and we pride ourselves on the quality of service we provide

• We are very vertically integrated; our capabilities include: machining, high-purity welding, cleanroom, PCB, box build, and design engineering

What we offer:

• Medical, dental, vision, voluntary benefits 

• PTO plan with paid winter shut down

• Supportive work/life balance culture

• 401k

ITAR Requirements

This position requires use of information which is subject to the International Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee.

MEI is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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