Quality Control Technician III; 2nd Shift

Position Title: Quality Control Technician III (2nd Shift)

Location: Irvine

Position Type: Full time

QC Technician III is proficient performing inspections and testing at various stages of production of the product—from raw materials, sub-assemblies, and final assemblies—to assure product quality and conformance to specifications and procedural requirements. QC Technician III analyzes problems, determines problem‑solving techniques, and exercises judgment in selecting appropriate solutions.

The following are the essential functions of this position. This position may be responsible for performing additional duties as tasks as needed and assigned.

• Interprets engineering drawings and schematic diagrams to complete incoming, in‑process, and final inspections.
• Able to use a wide assortment of QC inspection instruments to assure components and devices are manufactured and functioning according to specification.
• Records test data and interprets its pass/fail status.
• Performs and documents all QA inspection and testing activities to assure conformance to specifications.
• Performs label inspections.
• Audits various manufacturing processes to assure compliance and product segregation.
• Monitors quality products at all stages of manufacturing and packaging process to determine proper sampling and variations in the process.
• Reviews donor records for compliance.
• Compiles and reviews device history records to assure compliance and releases products to Finished Goods.
• Initiates non‑conformance reports (NCRs) and follows up to final disposition of nonconforming materials.
• Assists in developing and implementing Corrective and Preventive Actions (CAPAs) using known problem‑solving techniques. Assists in developing and implementing Document Change Orders (DCOs).
• Redlines/revises specifications as needed to assure QSR compliance.
• Trains other QC Technicians on new or revised procedures.
• Investigates and reports complaints on existing products as directed by QA Management.
• Fills out and processes quality reports and enters them into the computerized quality reporting database.
• Performs and/or assists special projects as directed by Quality Team Lead, Manager, or Director.

The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.

• High School Diploma or equivalent required.

• 7 years or more related experience. Knowledge of GMPs (QSR) and/or ISO 9001 and ISO 13485 regulations, medical device manufacturing experience, cleanroom manufacturing experience.
• Experience with usage of common inspection tools (e.g., rulers, calipers): read blueprint drawings. Knowledge of computer software programs including Microsoft Word & Excel.
• Experience with usage of inspection techniques and knowledge of statistical sampling plans. Strong attention to detail. Ability to balance and prioritize inspections and job responsibilities to support production. Focused with a strong sense of urgency.
• Good verbal and written communication skills, ability to communicate and interact well with all levels of personnel. Ability to work with a diverse group of people.

• Technical College
• Associate’s Degree
• Bachelor’s Degree

• ASQ Certifications such as but not limited to CQI or CQT.

• This position requires frequent or continuous moderate lifting of 15–40 lbs.
• This position requires frequent or continuous pushing and/or pulling.
• This position requires frequent or continuous standing.
• This position requires frequent or continuous walking.
• This position requires frequent or continuous repetitive motion involving substantial movements of the wrist, hands and/or fingers; or grasping with hands and/or fingers.
• This position requires frequent or continuous bending, stooping, kneeling, or crouching.
• This position requires frequent or continuous exposure to dust, fumes, gases, odors or other airborne irritants.
• This position requires…