Sr. Associate Quality Systems Specialist

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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Bachelors 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.

• Experience with ISO 13485:2016 and FDA quality system regulations.
• Familiarity with 21 CFR Partsand 211.
• Exposure to ISO 14971 and ISO 10993.
• Experience with MasterControl Jira JDE OneTrac SailPoint Adobe or similar systems.
• Experience supporting supplier quality programs SCARs or quality agreements.
• Knowledge of cosmetics or dietary supplement regulations.
• Experience with AI-enabled productivity tools and statistical software such as Microsoft Copilot Gemini or Minitab.
• Technical writing experience.
• Mandarin language proficiency.
• Demonstrated analytical problem-solving and project coordination skills.

• General office environment.
• Candidate must reside in or near Cork Ireland.
• Limited travel may be required.
• Flexibility to support U.S.-based business hours when needed.