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.

Position Summary

Reporting to the Director of Quality, the Quality Systems Specialist plays a key role in driving compliance, continuous improvement, and operational excellence across international markets. This individual serves as the CAPA Program Lead and owns the divisional quality metrics program, ensuring structured investigation, effective corrective actions, and meaningful performance monitoring. The role supports the maintenance and enhancement of the Quality Management System (QMS) in alignment with ISO 13485, FDA regulations, and other applicable international standards. Through cross-functional collaboration, audit support, and process ownership, the Quality Systems Specialist helps ensure regulatory readiness and sustained quality performance.

Key Responsibilities

CAPA Program Lead

Serve as CAPA Process owner and eQMS Business Process owner overseeing governance, CAPA Review Board facilitation, and cross-functional alignment.
Ensure CAPA investigations follow structured root cause analysis methodologies (e.g., 5 Whys, Fishbone Diagram).
Track and trend CAPA metrics, analyze effectiveness, and present findings to senior leadership.
Develop and deliver CAPA training programs to internal stakeholders, promoting awareness and compliance.
Lead CAPA Review Board meetings, ensuring timely review, approval, and closure of CAPA records.

Metrics

Develop, maintain, and own divisional quality metrics dashboards.
Track and trend CAPA metrics, complaint data, audit findings, and other quality indicators.
Analyze metric trends to identify systemic issues and improvement opportunities.
Present management review quality performance data to senior leadership and cross-functional teams.
Ensure metrics are aligned with regulatory expectations and internal quality objectives.

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

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 Qualifications/Experience

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, and ISO 14971.
Bachelor’s degree in science or engineering.
Strong CAPA experience with excellent analytical and problem-solving skills.
Customer-focused mindset aligned with organizational priorities.
Strong written and oral communication skills.
Excellent attention to detail and planning ability.

Preferred Qualifications/Experience

Technical writing proficiency.
High learning aptitude and adaptability with software systems.
Project management capabilities.
Ability to work effectively in dynamic environments.
Cultural awareness and sensitivity.
Knowledge of regulations for cosmetics and dietary supplements is a plus.
Proficient in MS Office (Word, Excel, SharePoint, PowerPoint).

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

Quality Systems Specialist (CAPA)

Benefits

Job Description