PrideStaff
Quality Inspector
needed for a HealthTech manufacturing company located near the Irvine Spectrum.
Temporary to Hire
role. Paying
$21-$27/hr , depending on experience. Hours are
Monday - Friday, 6:00 AM - 2:30 PM . Excellent benefits include 100% paid Medical, Dental, and Vision insurance for the employee and family members. This company takes pride in providing exceptional care for its employees and fostering a fun and engaging work environment.
Job Summary: We are seeking a detail-oriented and experienced Quality Control/Assurance Inspector to support both incoming and in-process inspections of medical device components and finished products. This role will be responsible for performing visual, dimensional, and functional inspections, reviewing documentation, and ensuring all processes and products comply with company standards, regulatory requirements, and ISO 13485.
Key Responsibilities: Perform visual, dimensional, and functional inspections on medical device components and finished products using hand tools, precision measurement equipment, and systems such as Keyence. Conduct First Article Inspections (FAIs) and Receiving/In-Process Inspections in alignment with GD&T and blueprint specifications. Interpret part drawings, including identification of critical vs. non-critical dimensions, and understand tight dimensional tolerances (down to the thousandths). Review and verify manufacturing and quality documentation, including Certificates of Compliance (COCs), labels, and Device History Records (DHRs). Ensure adherence to GMP, GDP, and SOPs, and provide feedback or escalate issues when deviations or nonconformances are found. Use AQL sampling plans and inspection procedures to assess compliance and quality. Accurately enter nonconformances and quality findings into the Quality Management System (QMS). Perform line clearance, document reviews, and verification of manufacturing documents against device drawings. Collaborate with cross-functional teams and provide feedback for continuous improvement. Maintain consistent and reliable attendance, with flexibility to support various tasks across the QA function. Qualifications:
Minimum 2 years of experience in Quality Control/Assurance, preferably in the medical device industry. Strong understanding of GMP, GDP, and ISO 13485 quality standards. Skilled in blueprint reading, GD&T, and FAI practices. Proficient in using precision tools: calipers, micrometers, rulers, and visual inspection tools. Experience using and/or programming Keyence systems is strongly preferred. Familiarity with COC issuance, label inspection, and documentation review. Excellent attention to detail, hand-eye coordination, and manual dexterity. Comfortable working with manufacturing software, ERP systems, and entering data into QMS. Strong communication skills (both written and verbal) and ability to provide/receive feedback. High School Diploma or equivalent required. Preferred Skills:
Experience with GR&R, Metrology, and AQL sampling. Working knowledge of QMS systems, traceability practices, and nonconformance documentation. Ability to work independently with minimal supervision and switch between different QC/QA tasks as needed.
Compensation / Pay Rate (Up to): $21.00 - $27.00 Per Hour
needed for a HealthTech manufacturing company located near the Irvine Spectrum.
Temporary to Hire
role. Paying
$21-$27/hr , depending on experience. Hours are
Monday - Friday, 6:00 AM - 2:30 PM . Excellent benefits include 100% paid Medical, Dental, and Vision insurance for the employee and family members. This company takes pride in providing exceptional care for its employees and fostering a fun and engaging work environment.
Job Summary: We are seeking a detail-oriented and experienced Quality Control/Assurance Inspector to support both incoming and in-process inspections of medical device components and finished products. This role will be responsible for performing visual, dimensional, and functional inspections, reviewing documentation, and ensuring all processes and products comply with company standards, regulatory requirements, and ISO 13485.
Key Responsibilities: Perform visual, dimensional, and functional inspections on medical device components and finished products using hand tools, precision measurement equipment, and systems such as Keyence. Conduct First Article Inspections (FAIs) and Receiving/In-Process Inspections in alignment with GD&T and blueprint specifications. Interpret part drawings, including identification of critical vs. non-critical dimensions, and understand tight dimensional tolerances (down to the thousandths). Review and verify manufacturing and quality documentation, including Certificates of Compliance (COCs), labels, and Device History Records (DHRs). Ensure adherence to GMP, GDP, and SOPs, and provide feedback or escalate issues when deviations or nonconformances are found. Use AQL sampling plans and inspection procedures to assess compliance and quality. Accurately enter nonconformances and quality findings into the Quality Management System (QMS). Perform line clearance, document reviews, and verification of manufacturing documents against device drawings. Collaborate with cross-functional teams and provide feedback for continuous improvement. Maintain consistent and reliable attendance, with flexibility to support various tasks across the QA function. Qualifications:
Minimum 2 years of experience in Quality Control/Assurance, preferably in the medical device industry. Strong understanding of GMP, GDP, and ISO 13485 quality standards. Skilled in blueprint reading, GD&T, and FAI practices. Proficient in using precision tools: calipers, micrometers, rulers, and visual inspection tools. Experience using and/or programming Keyence systems is strongly preferred. Familiarity with COC issuance, label inspection, and documentation review. Excellent attention to detail, hand-eye coordination, and manual dexterity. Comfortable working with manufacturing software, ERP systems, and entering data into QMS. Strong communication skills (both written and verbal) and ability to provide/receive feedback. High School Diploma or equivalent required. Preferred Skills:
Experience with GR&R, Metrology, and AQL sampling. Working knowledge of QMS systems, traceability practices, and nonconformance documentation. Ability to work independently with minimal supervision and switch between different QC/QA tasks as needed.
Compensation / Pay Rate (Up to): $21.00 - $27.00 Per Hour