Quality Operations Technician

Job Purpose

Quality Operations Support role for all Manufacturing Value Streams and supporting functions.

As a Quality Operations Technician, this role will play a crucial part in ensuring the quality and efficiency of our medical device manufacturing processes. You will actively contribute to the overall operational success of our manufacturing facility, with a specific focus on maintaining high-quality standards, adhering to regulatory requirements, and supporting the continuous improvement of our manufacturing operations.

Main Duties & Responsibilities

·       Maintain the standard of Good Manufacturing Processes and housekeeping requirements in line with Regulatory requirements

·       Documentation and Record-Keeping: Assist in maintaining accurate and up-to-date documentation related to manufacturing processes, quality controls, and compliance activities.

·       Review product on Quality Hold, investigate and determine disposition as required.

·       Completion of non-conformance reports and associated investigations with the support of the quality engineers.

·       Monitor manufacturing processes to identify any deviations from established standards and promptly report any issues or non-compliance

·       Support Quality System activities within value streams and across the site such as GMP process walks, complaint investigations and NR’s

·       Ensure that all relevant Quality KPI Data is recorded, reported and actioned in an efficient manner. (CAPA, NR, etc.)

·       Identify and carry out required Quality training including certification of production associates and roll out of quality alerts when required.

·       Participate in training programs to enhance knowledge of manufacturing processes, quality systems, and regulatory compliance requirements.

·       Ensure all Manufacturing Areas comply with GMP, ISO and QSR requirements.

·       Ensure that all Health, Safety and Environmental requirements are fulfilled.

·       Continuous Improvement: Collaborate with cross-functional teams to identify areas for improvement and support initiatives aimed at enhancing operational processes, product quality, and overall efficiency

·       Data Analysis: Assist in the analysis of manufacturing data to identify trends, patterns, and areas for improvement, contributing to process optimization and efficiency enhancement efforts.

Accountabilities

·       GMP adherence

·       Maintain Quality Metrics

·       Provide Training as required

·       Audit Prep

·       Document Management

Competencies

·       Attention to detail Pro-active approach to work

·       High Standards Flexible

·       Good Communication Skills Team Player (Written & Oral)

·       High level of Numeracy

·       Good Planner & Organiser