QC Technician

Job title:

QC Technician

R*eporting to:*

Quality Assurance Manager

Aim of the job:

Quality Control Inspection of Intelligent Fingerprinting Products in conformance with ISO 13485 and ISO 9001 requirements.

Ensuring high level of Quality for products at release to all customers

Key areas of responsibility:

• Performing QC for raw material inspections at Goods In.
• Performing QC for Delivered Readers at Goods in.
• Performing In Process QC inspection tasks
• Performing QC Release for fully packaged products for Customers
• Performing QC Release for Cartridges as required.
• Maintaining Calibration Control for Reader Manufacture on/off site
• Maintaining Calibration Check Cartridge Stock
• Generation of Drug Standards for QC testing
• Ensuring Quality Control Inspections are planned and managed in timely manner and that associated documentation is completed in line with ISO 13485 Compliance
• Ensuring that all aspects of inspection are captured and included within inspections, via updates to documentation
• Performing internal Audit Inspections within production and research and development, corrective actions and policing resolution and closeout.
• Assistance with Validations for IFP Products.
• Review of all future product validation protocols and reports.
• Validation testing of all future products. Responsible to deliver to agreed timelines
• QC sign off for incoming goods inspections performed
• QC sign off review for manufacturing reagents/components made within manufacture
• QC sign off for product titrations performed within IFP for manufactured product
• In line observation of product made within manufacture and ensuring manufacturing procedure for bad part marking is maintained
• QC testing of final product to drug threshold values and approval for release/updating of product release SOP’s
• Ongoing stability monitoring and testing
• Where masterbatch created, control & comparative testing
• To be involved in the production activities when required

Authorities:

No direct authorities, coordinating with QA manager and documentation control as priorities dictate

Behaviours:

Team player, communicative/approachable. Reliable. Required openness and transparency to all activities conducted. External communications.

Neat, methodical, process driven, detailed approach.

Key measures:

Delivery of QC inspection approvals in line with Manufacturing operational timelines.

Ensuring QC measures required are appropriately recorded and held within the QMS in accordance with ISO 13485/9001 requirements.

Education and experience required:

Experience within Laboratory or Technical workshop environment

Experience communicating with customers

Other:

Driving licence. Permission to work in UK.

Review: INITIAL / APPRAISAL / OTHER* *circle as appropriate

Reviewed by:

Name

Signed

Date

Employee

Line Manager

Job Types: Full-time, Permanent

Salary: Up to £23,000.00 per year

Benefits:

• Company events
• Company pension
• On-site parking

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Cambridge: reliably commute or plan to relocate before starting work (required)

Work Location: One location

Reference ID: IFP QC Technician