Quality Systems Specialist

Quality Systems Specialist (Change Control) page is loaded## Quality Systems Specialist (Change Control)remote type: Hybridlocations: Corktime type: Full timeposted on: Posted Todayjob requisition id: JR0137759McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care.What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you.**Position Summary**Reporting to the Director of Quality, the Quality Systems Specialist plays a critical role in ensuring regulatory compliance and operational excellence across McKesson Medical-Surgical. This individual is responsible for managing customer complaints, leading the division-wide change control process, and supporting the maintenance and continuous improvement of the Quality Management System (QMS). The role ensures alignment with ISO 13485, FDA regulations, and other applicable international standards, while collaborating cross-functionally to drive quality initiatives, ensure audit readiness, and uphold documentation integrity across the organization.**Key Responsibilities:****Customer Complaint Handling*** Receive, assess, and process product complaints from international customers.* Request additional information to fully understand reported events.* Evaluate complaints for potential regulatory impact and escalate as needed.* Support timely and accurate reporting in accordance with applicable international regulations.**Document Control*** Support with document change requests and the eQMS document workflow* Create new and update standard operating procedures.* Upload records into the eQMS using the QMS framework**Change Control Lead*** Lead and execute the division-wide change control process, ensuring timely initiation, review, and implementation of change requests.* Chair the Change Review Board (CRB), facilitating structured evaluation and decision-making for proposed changes.* Ensure regulatory and quality impact assessments are completed for all changes, in compliance with ISO 13485 and FDA regulations (including 21 CFR Part 820).* Coordinate cross-functional input from Quality, Regulatory, Operations, Supply Chain, and other relevant stakeholders.* Maintain accurate and complete change control documentation, ensuring traceability and audit readiness.* Monitor and report on change control metrics, identifying trends and opportunities for process improvement.* Develop and deliver training on change control procedures, roles, and responsibilities to ensure consistent execution across the organization.* Support internal and external audits by providing change control records and demonstrating compliance with applicable standards.* Ensure alignment of change control activities with broader quality system elements, including CAPA, risk management, and document control.**General QA/RA Support*** Prepare for and support internal, customer and regulatory audits (FDA, Notified Bodies, etc)* Maintain and enhance Quality Management System (QMS) in alignment with ISO 13485 and applicable regulatory requirements.* Maintain working knowledge of U.S. FDA regulations and international standards relevant to medical devices, cosmetics, and dietary supplements.* Support continuous improvement of quality and regulatory processes, including updates to SOPs and QMS documentation.**Required Experience/Education:*** Minimum 4 years’ experience in Quality Assurance and within the Medical Device or Pharmaceutical industry.* Familiarity with FDA regulations 21 CFR 117, 210, 211, 803, 806, 820, ISO 13485:2016, ISO 14971, and ISO 10993.* Bachelor’s degree in science or engineering or related discipline.* Strong analytical and problem-solving skills.* Customer-focused mindset aligned with organizational priorities.* Excellent attention to detail and planning ability.* Strong written and oral communication skills.* Proficient in MS Office (Word, Excel, SharePoint, PowerPoint).**Preferred Experience/Skills*** Technical writing proficiency.* High learning aptitude and adaptability with software systems.* Project management capabilities.* Knowledge of regulations for cosmetics and dietary supplements is a plus* Cultural awareness and sensitivity.At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves.As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. **Our Base Pay Range for this position**€49,800 - €83,000
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