We Make Life More Rewarding and DignifiedLocation: BallinaDepartment: QualitySenior Quality Engineer – 12 month contractJob SummaryWe are seeking a proactive and detail-orientedQuality Compliance Engineerto join our Quality Assurance team for a12 month contact. This role is a critical technical position responsible for ensuring that all medical device manufacturing activities meet the latest global regulatory requirements, includingISO 13485:2016and the fully implementedEU MDR.Your responsibilities will include completion of end-to-endvalidation lifecycle (IQ/OQ/PQ), performing rigorousrisk assessments (pFMEAs), and supporting thechange control processto maintain product integrity.In addition, you will be a primaryQuality Liaisonfor the production floor, supporting and driving root cause investigations and ensuring that manufacturing processes are stable, compliant, and ready for regulatory inspection.Key ResponsibilitiesProduct and Process Validation: Develop, review, and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes to ensure high-degree assurance of product requirements.Risk Management: Lead and maintain risk management files, including pFMEAs ensuring that all potential failure modes are identified and mitigated.Production Quality Support: Provide real-time QA support to the operations team to address non-conformances, perform root cause analysis, and implement effective CAPAs (Corrective and Preventive Actions).Audit Readiness: Support internal and external audits by maintaining accurate documentation and ensuring all plant personnel follow cGMP requirements.Statistical Analysis: Apply statistical techniques and tools (e.g., Minitab) to analyze process data, identify trends, and support data-driven decision-making for process improvements.Other duties as assignedQualificationsRequired:Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, or related field) or Life Sciences.5+ years of experience in quality assurance or Validation in the medical device or a similarly regulated industry.Solid understanding of ISO 13485, EU MDR, ISO 14971 and relevant medical device regulations.Strong analytical and problem-solving skills; experience with root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA).Excellent written and verbal communication skills, especially in technical writing and documentation.Proficient in data analysis tools such as Excel, Minitab, Power BI or similar.PreferredCertified Quality Engineer (ASQ CQE) or similar professional certification.Certified Internal or Lead AuditorKnowledge of EU MDR and international medical device regulations.Six Sigma or Lean Certification is a plus.CompetenciesStrong attention to detail and commitment to quality.Ability to manage multiple tasks and projects in a fast-paced environment.Collaborative mindset with ability to work effectively across departments.Self-motivated with a continuous improvement mindset.About Hollister IncorporatedHollister 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 StatementAll 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:35545