· Job facts
The Quality Assurance Technician III is responsible for supporting various and a wide variety of activities within manufacturing and the QA team to ensure compliance with applicable regulatory and ISO requirements. The Quality Assurance Technician III will compile and review metrics and make recommendations for improvements to existing processes. This position will play a lead role in the MRB process.
Such activities consist of but are not limited to; ensuring product meets established specifications and requirements, procedures are followed, records are accurate as well as appropriate, the Quality System is monitored and issues elevated when necessary. This position also requires decisions be made to determine appropriate actions are taken throughout processes as defined by our procedures.
•Create and monitor Non-Conforming Reports (NCRs) as required.
•Responsible to control and monitor quarantined and non-conforming materials.
•Understand the requirements of the Quality System such as; Good Documentation Practices, Quality Systems Procedures, Work Instructions, Quality Records, Verification activities, Audits, training, Design Transfers, Validations, Non-Conforming Product, CAPA, Production/Process Controls, ESD, Handling, and Document/Data Control.
•Compile, monitor and report Quality Assurance monthly metrics including identifying and/or preparing action plans for improvements.
•Compile and maintain Quality Assurance daily metrics reporting any significant impact or opportunity to Quality Assurance and Quality Engineer managers.
•Provide feedback to team members, operations and the Quality Assurance manager as appropriate.
•Responsible for routinely conducting departmental Quality and/or Safety Audits.
•Review, evaluate and disposition Quality Data; Review and evaluate quality records and Device History Records (DHRs) to ensure accuracy, completeness, appropriate release and control of product(s).
•Monitor Production Processes as required.
•Continuously promote “Right First Time.”
•Lead/participate in investigations (relating to problems, potential problems, failures and/or complaint data)
•Ensure compliance with quality system requirements as it applies to the output of the defined job specifications.
•Coordinate manufacturing and development projects (including Design transfers) as required.
•Participate in daily production meetings as required.
•Participate in continuous improvement initiatives.
•Align with Quality Assurance team members that best balance with Quality, Operation, and Corporate
Associate's Degree in a related field.
CQA, CQT or equally recognized formal certification in the field of Quality preferred.
4 years of experience working in the area of Quality.
Preferably 2 years' experience in an FDA and/or ISO regulated industry.
This position is 2nd shift working schedule.
· Who we are
Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, innovates and manufactures instruments and reagents that automate tissue processing and slide staining for cancer diagnostics. Our integrated staining, workflow management and digital pathology solutions optimize laboratory efficiency to reduce errors and support diagnosis for pathology professionals. Together with Roche, Ventana is driving personalized healthcare through accelerated drug discovery and companion diagnostics.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.