Quality Technician

JOB PURPOSE

Amcor Flexibles’ Sligo is seeking a dedicated Quality Assurance Technician to join our team. The role will support the quality department to contribute to the maintenance and enhancement of quality standards within our operations. The successful candidate will play a key role in ensuring compliance with regulatory requirements and upholding the highest levels of quality assurance. The role reports to the Quality Manager and works closely with operations and other key stakeholders.

Principal Accountabilities

• Monitor routine inspections and testing at various stages of the production process to verify compliance with specifications, quality, and factory standards.
• Assist in the development and implementation of quality control procedures and protocols.
• Coordinate and perform procedural updates and process improvements for quality documents such as SOP’s, Forms, Work Instructions, Training Manuals, Specifications Sheets, Risk Assessments etc.
• Maintain accurate and detailed records of quality assurance activities, inspections, and test results.
• Monitor and enforce Good Manufacturing Practices (GMP) throughout the manufacturing process & Perform GMP compliance audits.
• Oversee the training of new quality inspectors and technicians to ensure consistent quality standards throughout the department.
• Raise the operative’s awareness and effectiveness in producing high quality product in conjunction with the production team through training, monitoring, and coaching.
• Assist with the review and comparison of new/unusual/AQL defects found during routine production and provide guidance for quality inspectors on marginal product.
• Collaborate with cross-functional teams to investigate and resolve quality issues, including non-conforming materials and products. Complete the relevant documentation and ensure swift resolution.
• Coordinate and investigate quality events such as Non-Conformances, RCA’s, Change Controls, CAPA records and Opportunity for improvements to ensure accurate and timely closures.
• Investigate and resolve customer complaints to the satisfaction of all parties using problem solving and investigation tools such as 8D, 5 why, Ishikawa diagram etc.
• Contribute to the identification of areas for process improvement and drive the implementation of corrective and preventive actions (CAPA) & continuous improvement quality activities.
• Conduct troubleshooting and disposition inspections on materials, components, and finished products to ensure adherence to customer and regulatory requirements (internal/material rejections).
• Perform Supplier Management/ SCAR reporting duties for defective or rejected incoming materials.
• Prepare Change Controls for internal and customer changes. Obtain the necessary approvals and where necessary implement on the document control system.
• Assure the quality standards agreed with customers are achieved through review of customer specification and implementation of internal updates.
• Contribute to the continual improvement activities through participation, providing feedback/ suggestions for improvement.
• Coordinate Machine calibration requirements with the maintenance department and verify the work is completed to the required standard.
• Audit test equipment calibration to ensure working equipment is in compliance with SOP and regulatory requirements.
• Track and trend process data such as change controls customer complaints, internal quality rejections, supplier corrective action reports for Quality meetings, Management Monthly reporting, and Annual management reviews.
• Support the validation of equipment and processes related to quality assurance.
• Participate in internal and external audits, ensuring compliance with industry regulations and customer requirements.
• Maintain work area in a clean and orderly manner by practicing good housekeeping.
• Performs additional duties as requested by Team Leader/Management.

QUALIFICATIONS:

• A third level qualification in an appropriate discipline is desirable or additional certification in quality assurance.
• Proven experience in a quality role in the medical device industry.
• Working knowledge of a manufacturing process.
• Familiarity with relevant quality management systems and regulatory requirements.
• Knowledge of Continuous Improvement, Quality, and manufacturing systems such as FMEA, fishbone diagrams 5Whys, Change management, Lean manufacturing etc.
• Proficient in using quality testing equipment and tools.
• Knowledge of statistical methods and data analysis is a plus.

SPECIFIC SKILLS & ABILITIES

• Ability to work as an effective member of a high-performance team.
• Excellent communication skills both oral and written to ensure clear alignment.
• Ability to pay attention to details while meeting critical deadlines with ever changing priorities.
• Must have a positive attitude and open mindedness to new ideas.
• A self-starter who can prioritize their own work.
• Proven ability to drive continuous improvement within a complex manufacturing business.
• Cross culture awareness, sensitivity, and effective communications within a global organization.
• Ability to build strong working relationships with relevant persons (plant and corporate alike).

Must demonstrate a strong work ethic, reliability, trustworthiness, a capacity, and willingness to learn, and respectfulness towards co-workers.