Postitatud: Muu sees Edela Inglismaa | Posted: |
The Role
To ensure quality assurance and compliance of products, materials, processes, and documentation relating to medical device manufacture, goods in inspection, in-process inspection and final product testing.
Responsibilities
Inspecting materials, equipment, processes, and products – goods in inspection, in-process QC checks, and final functional testing.
Testing the products and analysing the results.
Reviewing batch records, ensuring error-free manufacturing and batch release, including improving batch record templates.
Ensure regulatory compliance of facility management and services, e.g., cleanroom maintenance and provision of adequate resources.
Creating/enhancing tooling descriptions, performing calibrations and ensuring the calibration & maintenance log is kept up to date and non-conforming tools are removed from the manufacturing environment.
Recommending and executing corrective actions and improvements.
Contribute to maintaining quality system-related documentation including supplier records, audits, purchase and manufacturing batch information, and corrective and preventive action forms.
Provide technical support and resolve quality issues with suppliers, customers or auditors.
Support audits and inspections.
Participate in internal auditing programmes.
Support investigation, analysis, and closure of relevant NCRs.
Working on corrective actions from non-conformances.
Identify potential quality & patient safety risks and raise risks with relevant individuals/department.
The Candidate
Strong understanding of quality assurance and manufacturing processes.
Experience with NCRs and CAPAs.
Experience in Quality Control functions such as inspection and measurement.
Experience in electronics.
Engineering qualification.
Experience of electro-mechanical assemblies in medical device, aerospace, or defence sectors
Able to read and follow technical drawings and instructions to high-quality standard.
Experience in visual inspection and excellent eye for detail.
Familiar with test/inspection equipment such as oscilloscopes, Multimeters and digital callipers.
Knowledge of and worked to the requirements of industry standards e.g. IPC-A-600, IPC-A-610 and quality management systems such as ISO13485, AS9100 or ISO9001.
Salary
The salary offered for this position is £28,000- £38,000 pa to a candidate that can meet all key qualifications and abilities.
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