Quality Control EngineerBrightpath Associates LLC • Irvine, CA, United States
Quality Control Engineer
Brightpath Associates LLC • Irvine, CA, United States
job_description.job_card.variable_hours_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionQualify and onboard new suppliers; conduct supplier audits and evaluations. Define incoming inspection requirements to ensure component conformance. Manage supplier non-conformances and issue Supplier Corrective Action Requests (SCARs). Partner with suppliers to drive process improvements and implement corrective actions. Perform incoming, in-process, and final inspections of extruded, shrink, and braided tubing. Conduct First Article Inspections (FAIs) and maintain accurate inspection records. Develop and execute test methods and protocols for product performance and reliability. Track and analyze production quality metrics (scrap rate, yield, defect rate). Calibrate and maintain inspection tools and metrology equipment. Utilize precision tools such as micrometers, laser micrometers, pin gauges, tensile testers, etc. Ensure visual and dimensional quality meets specifications and customer requirements. Initiate and manage Non-Conformance Reports (NCRs) and assist in root cause analysis. Maintain calibration logs to ensure all inspection instruments are current and accurate. Bachelor’s degree in Materials Engineering, Quality, Mechanical, or a related technical field. 2+ years of experience in QA / SQE / QC roles within the medical device industry (preferred). Familiarity with catheter manufacturing processes (extrusion, shrink tubing, or braiding) strongly preferred. Solid understanding of ISO 13485 and FDA QSR (21 CFR Part 820) requirements. Proficiency with quality tools such as CAPA, FMEA, 5 Whys, and Fishbone Diagrams. Strong attention to detail, documentation, and organizational skills. Hands-on experience with inspection techniques and measurement equipment. Ability to excel in a fast-paced, startup environment. Excellent communication, analytical, and problem-solving skills. Experience in catheter manufacturing processes. ASQ certification (CQE, CQA, or equivalent). Mandarin language proficiency is a plus.
Job Title : Quality Control (QA / SQE / QC) Engineer
Location : Irvine, CA (On-site)
Job Overview :
We are seeking a highly motivated and detail-oriented Quality Control Engineer to join our team in Irvine, California. The ideal candidate will support Quality Assurance (QA), Supplier Quality Engineering (SQE), and Quality Control (QC) functions, ensuring compliance with ISO 13485 and FDA 21 CFR Part 820. This role plays a key part in maintaining product integrity and driving continuous improvement in manufacturing processes.
Key Responsibilities :
Quality Assurance (QA) – Process / System-Focused
- Develop, implement, and maintain a compliant Quality Management System (QMS) per ISO 13485 and FDA 21 CFR Part 820.
- Lead internal and external audits; manage CAPA processes and follow-up activities.
- Conduct risk assessments (e.g., PFMEA) and ensure integration of quality into product development and manufacturing.
- Create, revise, and control SOPs, work instructions, forms, and quality records.
- Support equipment and process validations (IQ, OQ, PQ) for tubing manufacturing processes.
- Participate in customer audits and regulatory inspections.
- Collaborate with cross-functional teams (Engineering, Production, R&D) to define CTQ (Critical-to-Quality) parameters and ensure product quality.
- Maintain and organize Device History Records (DHRs), Device Master Records (DMRs), and training logs.
Supplier Quality Engineering (SQE) :
Quality Control (QC) – Product-Focused
Qualifications :
Preferred Qualifications :
serp_jobs.job_alerts.create_a_job
Quality Control • Irvine, CA, United States
Job_description.internal_linking.related_jobs
Ardmore Home Design (AHD), founded in 2008, is a privately owned, fast-paced, founder-led entrepreneurial company where we value people with strong skills to make our products and processes better ...serp_jobs.internal_linking.show_more
With a commitment to excellence and innovation, we specialize in designing, manufacturing, and delivering high-performance solutions for our clients worldwide.
Our team comprises passionate professi...serp_jobs.internal_linking.show_more
Arrow Route, Rancho Cucamonga, CA, 91730, US.Remote Work Schedule Availability?.This position entails access to export-controlled items and employment offers are conditioned upon an applicant's abi...serp_jobs.internal_linking.show_more
A company is looking for a Quality Engineer located in Memphis, TN.Key Responsibilities Design, develop, and sustain quality processes and inspection methods, including procedures and documentati...serp_jobs.internal_linking.show_more
The Quality Control (QC) Technician plays a pivotal role in ensuring the highest standards of quality by reviewing, inspecting, dispositioning, approving, and releasing raw materials, labeling, and...serp_jobs.internal_linking.show_more
A food production company in San Clemente is searching for a.This individual will be responsible for in-plant process testing and compliance to company standards.
Must be able to work in all tempera...serp_jobs.internal_linking.show_more City of Industry, CA, 91744, US.Remote Work Schedule Availability?.This position entails access to export-controlled items and employment offers are conditioned upon an applicant's ability to lawfu...serp_jobs.internal_linking.show_more 
Professional Plastics is a leading distributor of high-performance engineering plastic shapes.We provide the widest range of engineering plastics, composites & technical ceramics in the marketp...serp_jobs.internal_linking.show_more
NURA is seeking a Quality Analyst to help our growing team.Primary responsibilities will be inspecting and testing raw materials to meet our quality standards to include maintaining our lab equipme...serp_jobs.internal_linking.show_more
Some of the duties of this position are those described below.This job description does not state or imply that the duties listed are the only duties and responsibilities assigned to this position....serp_jobs.internal_linking.show_more
Shift (6 : 00 AM) & 2nd Shift (2 : 30 PM).The Final Inspector is responsible for ensuring that finished products meet customer specifications and company quality standards.This includes performing ...serp_jobs.internal_linking.show_more
Inc is seeking a full time Junior Quality Inspector to join our team.You will conduct tests to determine the quality of finished materials and finished products.
Alternative Workweek Schedule - ...serp_jobs.internal_linking.show_more S State College, Fullerton, CA, 92831, US.S Placienta Ave, Fullerton, CA, 92831, US.Remote Work Schedule Availability?.This position entails access to export-controlled items and employment offers ...serp_jobs.internal_linking.show_more 
Ardmore Home Design (AHD), founded in 2008, is a privately owned, fast-paced, founder-led entrepreneurial company where we value people with strong skills to make our products and processes better ...serp_jobs.internal_linking.show_more
The Quality Control Inspector for Machined Parts is responsible for ensuring that machined components meet specified quality standards, tolerances, and customer requirements.This role involves insp...serp_jobs.internal_linking.show_more
Quality Control department during the manufacture and release of Bio-Rad control products.This position will work both independently and in a team-oriented environment.
This position is for a second...serp_jobs.internal_linking.show_more S State College, Fullerton, CA, 92831, US.Remote Work Schedule Availability?.This position entails access to export-controlled items and employment offers are conditioned upon an applicant's abilit...serp_jobs.internal_linking.show_more 
General Responsibilities include : .Assist managers in registering bioprocesses info.Follow Chief Scientific officer and quality assurance.
CAPA and deviation investigation and analysis.Oversees the e...serp_jobs.internal_linking.show_more A company is looking for a Customer Quality Engineer to ensure customer quality and reliability requirements are met while addressing any quality issues.
Key Responsibilities Review customer quali...serp_jobs.internal_linking.show_more 
You will be working at a Major Automotive Manufacturer.Working hours from 10 : 00 AM to 7 : 00 PM.Quality Control Inspector experience.
NCR (Non Conformance Report) and RFD (Request for Deviation) proce...serp_jobs.internal_linking.show_more
Quality Control Lead
Ardmore Home Design • City of Industry, CA, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Quality Control Inspector - 2nd shift
Design West Technologies, Inc. • Tustin, CA, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Quality Engineer
Howmet • Rancho Cucamonga, CA, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
Quality Engineer
VirtualVocations • Ontario, California, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Quality Inspector
Aerotek • Irvine, CA, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Quality Control Associate
PrideStaff • San Clemente, CA, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Quality Engineer (Aerospace)
Howmet • City of Industry, CA, United States
serp_jobs.job_card.full_time +1
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Quality Control Inspector
Professional Plastics • Chino, CA, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Quality Control Analyst
Nura • Irvine, CA, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Quality Control Inspector I ( 2nd & 3rd )
Del Real Foods • Mira Loma, CA, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Quality Control Inspector
Fairway Staffing Solutions • Anaheim, CA, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
Junior Quality Control Inspector
D W Mack Co Inc • Azusa, CA, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Controls Engineer
Howmet • Fullerton, CA, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Quality Control Lead
Ardmore Home Design Inc • Hacienda Heights, CA, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Quality Control Inspector
Rubicon Gear Manufacturing Co • Corona, CA, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Quality Control Technician I
Bio-Rad Laboratories • Irvine, CA, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
Quality Engineer II
Howmet • Fullerton, CA, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Quality Control Lead-Biotechnology
Leo Corps, Inc. • Aliso Viejo, CA, US
serp_jobs.job_card.full_time +1
serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
Customer Quality Engineer
VirtualVocations • Moreno Valley, California, United States
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
Quality Control Inspector
CCS INC • Santa Ana, CA, US
serp_jobs.job_card.full_time
serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted