Sr. Associate Quality Systems Specialist

McKesson 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.

McKesson Medical-Surgical is seeking a Senior Quality Systems Specialist to support our Quality Management System (QMS) and ensure compliance with medical device regulations and international quality standards. This role is responsible for processing customer complaints, maintaining quality records, supporting audits, administering document control activities, and contributing to continuous improvement initiatives. The ideal candidate will bring experience in quality assurance within the medical device, pharmaceutical, or regulated healthcare industry and possess a strong understanding of ISO 13485, FDA regulations, CAPA processes, and quality system documentation.

Quality Systems & Compliance Maintain and process quality records within the electronic Quality Management System (eQMS), including complaints, CAPAs, deviations, nonconformances, and change controls. Ensure records are complete, accurate, and properly routed for review and approval. Support the maintenance and continuous improvement of the Quality Management System (QMS). Assist in preparing for internal, customer, and regulatory audits. Customer Complaint Management Receive, assess, and process product complaints from global customers. Gather and document relevant information to support complaint investigation activities. Escalate complaints with potential regulatory impact in accordance with established procedures. Support timely complaint reporting and documentation compliance. Document Control & Training Administer document control activities including issuance, revision, distribution, archival, and obsolescence processes. Support employee training assignments and training record reconciliation activities. Monitor and follow up on overdue training requirements. Investigation & CAPA Support Compile evidence, timelines, and supporting documentation for investigations. Contribute to root cause analysis and CAPA activities. Assist with effectiveness checks and documentation of results. Support implementation of corrective and preventive actions. Reporting & Supplier Quality Support Maintain quality metrics, dashboards, and performance trackers. Analyze data accuracy and identify discrepancies for correction. Assist with supplier quality documentation review, SCAR tracking, and audit readiness activities. Prepare routine reports and quality data summaries for stakeholders.

Bachelor's degree in Science, Engineering, Life Sciences, Quality, or a related field or equivalent combination of education and experience . 2+ years of experience in Quality Assurance, Quality Systems, Regulatory Affairs, or a related quality function within a regulated industry. Experience working in the medical device, pharmaceutical, biotechnology, or healthcare manufacturing industry. Knowledge of Quality Management Systems (QMS) and electronic quality systems (eQMS). Experience supporting customer complaints, CAPA, document control, quality records, or audit activities. Strong written and verbal communication skills. Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint. Preferred Skills & Experience Experience with ISO 13485:2016 and FDA quality system regulations. Familiarity with 21 CFR Parts 803, 806, 820, 210, and 211. Exposure to ISO 14971 and ISO 10993. Experience with MasterControl, Jira, JDE,