Medical Devices jobs in Cork, County Cork

About the Role

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.

What You'll Do

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.

Basic Requirements

• 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, 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.

Travel, Work Environment & Physical Requirements

• 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.