Quality Inspector needed for a HealthTech manufacturing company located near the Irvine Spectrum. Ideal candidate will have a strong Quality Control and Quality Assurance background.
This is a Temporary position going for six (6) months. Paying $21-$27/hr, depending on experience. Hours are Monday - Friday, 6:00 AM - 2:30 PM. (could change to 7:00 AM - 3:30 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.
Seeking a candidate with strong skills and a background in Quality Assurance and Quality Inspection. The individual will cover incoming inspections, including FAI, GD&T, and blueprint reading, as well as quality assurance tasks, such as document review, label inspections, COC issuance, and in-process inspections. Assesses devices in-process and upon completion, reviews accompanying documentation, and conducts audits to ensure that all comply with regulatory and company guidelines, and that devices meet operational standards as designed.

REQUIREMENTS:

• Must have 2 years experience of Medical Device experience, including GMP and GDP .
• Must be able to interpret part drawings.
• Understand critical and non-critical dimensions (and the difference between them).
• Perform first article inspections (FAIs).
• AQL measurements.
• Understand dimensional tolerances and down to the thousands.
• Strong background in QC inspections relating to paperwork and label review.
• Using and being able to manually measure a part with a Keyence system is preferred.
• Must be able to read blueprints.
• Must be able to use hand tools and precision tools for measuring, including micrometers, calipers, and rulers.
• Knowledge of COC insurance (Certificate of Compliance).
• High School Diploma or Equivalent.
• ISO background is a plus
• Must be able to jump around and wear different hats as needed.
• Good communication skills.
• Good reading, comprehending, and speaking communication skills.
• Basic computer skills are required, including working knowledge of manufacturing software, ERP systems, etc.
• Strict attention to detail.
• Ability to use applicable tools and equipment, hand-eye coordination, and high manual dexterity.
• Complete understanding of applicable inspection procedures.
• Continuously expands proficiency in inspection techniques.
• Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System).
• Must be able to work in a team environment and with minimal supervision by following detailed work instructions.
• Ability to effectively provide and accept feedback from colleagues.
• Adhere to all company rules and requirements.
  Job Types: Full-time, Temp-to-hire
  Pay: $21.00 - $27.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work Location: In perso

• Perform visual, dimensional, and functional inspections on a broader variety of components and/or finished medical device products using a wide range of tools and equipment.
• Conduct documentation reviews to ensure compliance with applicable procedures and documentation standards.
• Review, follow, and perform job functions in compliance with established work instructions and adherence to SOPs, including recording traceable information on device history records and utilizing a variety of computer programs to perform and/or document specific job tasks.
• Provide core team feedback, including escalating work issues and changes in the final devices and raw materials to higher levels (e.g., Engineering Support) for assessment and correction.
• Perform line clearance and verification of inspection.
• Perform verification of manufacturing documents with component and device drawings.
• On time arrival to work with regular attendance without excessive absenteeism.