Quality Control Technician III (2nd Shift)

Orthofix•Irvine, CA

5d•Onsite

About The Position

The QC Technician III is proficient in performing inspections and testing at various stages of production, from raw materials to final assemblies, to ensure product quality and conformance to specifications and procedural requirements. This role involves analyzing problems, determining problem-solving techniques, and exercising judgment in selecting appropriate solutions. The company, Orthofix, is a global medical technology provider with over 1,600 employees, focused on improving people's quality of life through innovative, cost-effective, and user-friendly medical technologies. They value collaboration, innovation, and a results-driven approach.

Requirements

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).
Ability to 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.

Nice To Haves

Technical College Associate’s Degree
Bachelor’s Degree
ASQ Certifications such as but not limited to CQI or CQT

Responsibilities

Interprets engineering drawings and schematic diagrams to complete incoming, in-process, and final inspections.
Uses 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 product in 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 (CAPA's) using known problem-solving techniques.
Assists in developing and implementing Document Change Orders (DCO's).
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 with special projects as directed by Quality Team Lead, Manager or Director.