Job Description
<p><strong><span style="font-family: Tahoma, sans-serif; color: black">JOB PURPOSE: </span></strong><span style="font-family: Tahoma, sans-serif">To fulfil and complete the quality control functions of quality control, measurement, and document control functions within the production environment under GMP, GDP and QMS standards, supporting continuous improvement, customer requirements and regulatory compliance.</span></p><p style="text-align: justify"><strong> </strong></p><p style="text-align: justify"><strong><span style="font-family: Tahoma, sans-serif; color: black">RESPONSIBILITIES:</span></strong></p><p style="text-align: justify"><strong> </strong></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Complete visual, functional and measurement (CMM, Vision System, Manual Gauges) inspections on production samples as per the defined sampling plans.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Ensure compliance with data integrity and record retention policies.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Timely and accurate reporting, analysis and communication of conforming/non-conforming product, visual defects, measurement trends and ‘Out of Spec’ results.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Aid in the resolution of customer complaints and non-conforming product</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Aid in the timely release of in process product to the customer in accordance with policies, procedures and guidelines.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Correct storage of samples and maintenance of sample area</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Assisting on and ensuring checkbacks are carried out as procedure.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Ensuring the shift is compliant with all MGS standards, processes & procedures, and reporting any non-conformances.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Ensure that the correct number of data/samples has been gathered as per requirements.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Assist during validation/engineering trials as required- accurate reporting, analysis and communication of results.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Assist metrology engineer on MSA/Gauge R&R.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Assist in training of associates for techniques and use of Metrology Lab equipment and supporting any training activities with their shift.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Maintaining a current and accurate record of works complete.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Ensure all shift paperwork is completed, GDP compliant and located/filed in the appropriate location.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Line clearance verification appointee for shift.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Pro-actively ensuring GMP, EHS and housekeeping standards are maintained throughout the MGS site.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Assist and support all continuous improvement activities to include but not limited to GMP, GDP, etc.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Proactively engage in continuous professional development.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Ensure adherence to company safety rules, SOPs, and QMS policies.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">proactively maintain GMP, GDP, EHS, and housekeeping standards across laboratory and production environments.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Support and participate in internal and external audits, CAPA activities, and non-conformance investigations.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Assist in continuous improvement initiatives within quality, metrology, and documentation processes.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Train operators and team members on measurement techniques, metrology equipment use, and documentation practices.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Collaborate with cross-functional teams to resolve customer complaints and quality issues efficiently.</span></p><p> </p><p><span style="font-family: Tahoma, sans-serif">The above list of duties and responsibilities is not exhaustive, and the role holder may be required to carry out other duties which may reasonably be assigned by management.</span></p><p style="text-align: justify"> </p><p style="text-align: justify"><strong><span style="font-family: Tahoma, sans-serif; color: black">THE IDEAL CANDIDATE WILL:</span></strong></p><p style="text-align: justify"><strong> </strong></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif; color: black">Have previous experience working in a GMP compliant environment.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif">Possess excellent verbal and written communication skills.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif; color: black">Have strong information management and analytical skills.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif; color: black">Have the ability to multitask in a fast-paced environment.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif; color: black">Be proficient in MS Office and standard laboratory information management systems.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif; color: black">Have previous experience working in a quality control/assurance role and/or in a laboratory setting.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif; color: black">Knowledge of dimensional measurement software (MeasureMind) and metrology principles.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif; color: black">Strong data analysis, information management, and problem-solving skills.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif; color: black">Team player with the ability to work independently and take initiative.</span></p><p> </p><p><strong><span style="font-family: Tahoma, sans-serif; color: black">Qualifications, Education, Experience, and Training</span></strong> </p><p> </p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif; color: black">A high school diploma or equivalent is required. Students with a background in quality engineering, metrology, or a related technical field are preferred.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif; color: black">2-4 years of experience in quality control/assurance, metrology, or document control in a GMP-regulated environment, such as a medical device or high-precision manufacturing company.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif; color: black">Prior training in GMP, GDP, and QMS practices; dimensional measurement systems (CMM, vision systems, and Keyence); and document control systems.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif; color: black">Training in the interpretation of 2D drawings and GD&T is preferred.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif; color: black">Experience using MeasureMind and laboratory information management systems. Advanced skills in Microsoft Office (Excel, Word, and PowerPoint) are required.</span></p><p><span>·</span><span style="font-family: Times\ New\ Roman"> </span><span style="font-family: Tahoma, sans-serif; color: black">English B2 Intermediate.</span></p>
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