Jobid=631821719482338978 (0.0174)
ppSelect how often (in days) to receive an alert: /p pbWe Make Life More Rewarding and Dignified /b /p h3Summary: /h3 pThe Senior Quality Assurance Specialist supports and strengthens the facility Quality Management System (QMS) to help meet applicable regulatory, compliance, and product quality requirements. The role leads or contributes to quality projects, process analysis, audits, investigations, risk assessments, validation activities, and cross-functional improvement initiatives. It partners with Operations and Global Quality stakeholders to ensure procedures, records, training, and quality decisions are clear, compliant, and aligned with organizational quality objectives. /p pHollister operates in a hybrid work environment. Associates are expected to come to Roosendaal facility a minimum of 4 days per week. /p h3Responsibilities: /h3 ul liApply advanced knowledge of medical device quality systems, external regulatory requirements, and quality assurance practices to support compliant facility operations. /li liLead or support site-specific QMS processes, work instructions, quality records, documentation controls, and training related to assigned areas of expertise. /li liPrepare for, execute, and support internal, external, and regulatory audits, including follow-up actions and evidence of compliance. /li liProvide sound quality input on material disposition, process controls, change controls, CAPA activities, and related compliance or product quality decisions. /li liPresent complex quality, risk, and compliance information in a clear, concise, and well-documented manner suitable for review by internal stakeholders or regulatory bodies. /li liUse structured problem-solving approaches such as Fishbone analysis, DMAIC, 5-Whys, or similar tools to identify root causes and implement effective corrective and preventive controls. /li liLead or participate in cross-functional and global project teams using project management fundamentals to drive quality-related deliverables. /li liFacilitate or support process FMEA, risk assessments, validation planning, and risk-based validation strategies. /li liCoach, train, and mentor colleagues in relevant quality processes, documentation expectations, audit readiness, and technical quality practices. /li liPerform other quality-related duties as assigned, consistent with the scope and seniority of the role. /li /ul h3Essentials of the Role: /h3 ul liMaintain and improve assigned QMS processes, procedures, records, and supporting documentation in accordance with applicable quality and regulatory requirements. /li liExecute or support audits, investigations, CAPA actions, change controls, risk assessments, validation activities, and other quality system deliverables. /li liReview, analyze, and document quality information with accuracy, attention to detail, and appropriate technical judgment. /li liCommunicate quality expectations, risks, findings, and decisions clearly to cross-functional stakeholders, including Operations and Global Quality partners. /li liSupport audit readiness by ensuring documentation, evidence, and process knowledge are current, understandable, and inspection-ready. /li liCollaborate effectively in team settings and contribute to a culture of compliance, continuous improvement, and product quality. /li liUse relevant digital tools and systems to document, track, report, and communicate quality activities. /li liWorking knowledge of ISO 13485, GMP, GDP, and other applicable quality/regulatory frameworks /li /ul h3Must have Requirements: /h3 ul liNumber of Overall Years Necessary: 5-8 /li liMinimum of 2-5 years in Quality position required within experience in the Good Manufacturing Practice Regulated Pharma/Medical Device industry. Additionally experience in a Distribution Quality Role would be advantageous as would expertise in TWI training methodology /li liBachelor’s degree or equivalent education/experience in a relevant technical discipline such as quality, engineering, life sciences, medical device, pharmaceutical, food science, or a related field. /li liRelevant quality assurance experience in a regulated environment, preferably within medical device, pharmaceutical, GMP/GDP, distribution quality, or a comparable technical setting. /li liDemonstrated experience supporting QMS processes, audits, documentation, investigations, CAPA, change control, risk assessment, or validation activities. /li liAbility to write clear technical reports, procedures, risk assessments, and quality documentation that can withstand internal and external review. /li liStrong communication, collaboration, prioritization, and stakeholder management skills. /li liProficiency with standard computer applications and quality-related systems used to manage records, documentation, investigations, and project activities. /li liAbility to communicate both verbally and in written form in English Dutch. /li /ul h3Preferred Requirements: /h3 ul liAuditor training or demonstrated experience preparing for, conducting, or hosting internal, external, or regulatory audits. /li liExperience in distribution quality or regulated distribution center operations. /li liExperience with Training Within Industry (TWI) or a comparable training methodology. /li liExperience applying structured problem-solving, process FMEA, risk-based validation, and project management practices. /li liAbility to coach, teach, or mentor others in quality system processes, technical documentation, or audit readiness. /li /ul pThe salary range for this position is 52,000 – 74,000 EUR annually. /p h3About Hollister Incorporated /h3 pHollister 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 and its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings. /p h3EOE Statement /h3 pAll 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. /p pJob Segment: Compliance, Quality Assurance, Facilities, Project Manager, Network, Legal, Technology, Operations /p /p #J-18808-Ljbffr
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