In PersonOn-site at the Carlsbad, California facility.
Manufacturing Quality & TestQuality Engineering, Validation, Compliance & Quality Systems
About the job
Requirements
A bachelor's degree or equivalent experience is required; ASQ certifications are desired.
At least five years of experience in quality assurance functions is required.
At least three years of contract manufacturing experience is preferred.
Previous experience with and understanding of ISO 9001, AS9100, ISO 13485, ISO 14001, AS9102, and FAR-DFAR documentation is required.
Familiarity with quality testing tools and procedures is required.
Familiarity with IPC 600, IPC 610, IPC 620, and J-STD-001 is preferred.
Strong English communication skills and the ability to create and write clear, detailed records and documents are required.
Strong computer skills, including Microsoft Office, and the ability to perform assigned duties within the ERP system are required.
The ability to work independently, stay focused, and perform in a fast-paced, deadline-driven environment is required.
Good analytical and problem-solving skills and attention to detail are required.
Interpersonal and teamwork skills sufficient to work with people across positions and personalities are required.
The ability to read and interpret prints and drawings is required.
Applicants must be U.S. persons as defined by ITAR: U.S. citizens, U.S. permanent residents, political asylees, or refugees.
Responsibilities
Manage the company's integrated quality management system, including certification to AS9100, ISO 13485, and ISO 14001 standards.
Monitor and audit the quality of manufactured goods using tools defined by the quality management system, enterprise resource planning system, and process work instructions and methods.
Support product testing and inspection to ensure products meet specified standards, and support process engineering in evaluating process quality and improving product quality.
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, and customer audits.
Lead problem-solving efforts, including investigating and analyzing customer complaints, resolving quality issues, and maintaining the tracking system.
Review and approve program nonconformances and material review board dispositions.
Review customer contract documents, including contractual documents, purchase orders, statements of work, attachments, and specifications, and work with program management and process engineering to ensure flow-down requirements are included in sales orders and process methods for conforming shipments.
Assist process engineering in developing and releasing inspection criteria and standards to ensure products are built to customer requirements.
Analyze 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 process.
Work with procurement to flow down quality requirements to suppliers.
Initiate corrective and preventive action activities for nonconforming products, including investigation, follow-up, and root-cause analysis; manage corrective and preventive action activity for timely completion in assigned work centers.
Assist in planning and presenting at the quarterly management review meeting.
Administer the electrostatic discharge and foreign object debris programs.
Process reason codes in the enterprise resource planning system and enter them into the company's statistical quality control and statistical process control requirements.
Promote and complete 6-S and Kaizen training and events.
Desired Qualifications
ASQ certifications are desired.
At least three years of experience in a contract manufacturing background is preferred.
Familiarity with IPC 600, IPC 610, IPC 620, and J-STD-001 is preferred.
Summary
The Quality Assurance Engineer (QAE) manages the company's 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.