Ballina Quality Technician MY F26 F3X5

Job description

The Quality Assurance (QA) Technician performs laboratory testing and quality control activities to support protocols, process qualification/certification, supplier approval, and new product introduction. The role executes validated/approved test methods, ensures data integrity and traceability in line with Good Documentation Practices (GDP), and partners with Engineering, Manufacturing, Supply Chain, Quality, and R&D to enable timely, compliant product release and continuous improvement. Responsibilities Plan and perform laboratory testing of materials and products per approved methods to support protocols, process control/qualification studies, and new product approval. Record, analyze, and report results with accuracy and completeness; escalate nonconformances and support investigations as required. Support validation/qualification activities for new or modified equipment and processes in accordance with procedures. Conduct audits/inspections of products from external suppliers and compile clear, actionable reports. Calibrate or coordinate calibration of laboratory equipment; maintain calibration and maintenance records. Perform machine waste/defect analysis; collaborate with cross‑functional teams to identify root causes and recommend corrective actions to reduce scrap and rework. Compile release documentation for finished products and support product disposition activities in line with procedures. Apply Good Documentation Practices (GDP) in reviewing production and test records for accuracy and completeness. Contribute to standard operating procedures (SOPs), work instructions, and training materials; share knowledge with peers. Maintain a safe and compliant laboratory environment; follow EHS and quality system requirements. Other duties as assigned. Perform visual and dimensional inspections and laboratory tests using computerized test equipment and standard tools. Read and interpret procedures, specifications, and test methods; communicate clearly in writing and verbally. Operate office and laboratory equipment; perform keyboard‑intensive work; maintain accuracy and focus during repetitive tasks. Work independently and collaboratively to meet priorities and timelines; typical travel requirement: none. Essential Functions of the Role Inspect goods for damage or discrepancies and report issues promptly. Conduct audits and inspections (internal and supplier). Maintain scientific and regulatory compliance in all clinical communications. Education & Work Requirements Relevant Degree with 2-4 years of related experience Education & Work Preferences Post‑secondary qualification (certificate, diploma, or degree) in a scientific or engineering discipline. Typically 2-3 years of relevant experience in quality, manufacturing, or laboratory environments, including at least 2 years of hands‑on laboratory testing experience. Proficiency using computerized laboratory test equipment and basic computer applications; ability to follow SOPs and apply GDP. Strong attention to detail, organization, and problem‑solving skills; ability to manage multiple tasks Experience in medical device or other regulated manufacturing environments and exposure to validation activities. Familiarity with quality systems and tools (e.g., ISO 13485, GMP, SPC, CAPA, Minitab/other statistical tools). Experience supporting supplier/product audits and continuous improvement (e.g., Lean/5S). About Hollister Incorporated Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings. EOE Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Job Req ID: 36838 Job Segment: Quality Assurance, Supply Chain, Compliance, Law, Supply, Technology, Operations, Legal Apply now » Find similar jobs: View All Jobs, Hollister - View All Jobs, Hollister - Ballina, Ireland Jobs, Ballina, Ireland Jobs Hollister.com Safe Harbor Privacy Policy Cookie Usage Equal Opportunity Employer and Accommodations Affirmative Action/ EEO Policy Statement ©2016 Hollister Incorporated