Quality Systems Engineer: CAPA & Compliance

McKesson; Shepherdsville, Northern (KY, KY); Hybrid; USD 79,000 - 132,000; Full time

Job summary

McKesson is seeking a quality systems professional to develop, implement, and maintain quality programs ensuring regulatory and client requirements are met. The role provides site-level QA oversight across operations, inspections, CAPA, temperature monitoring, and quality metrics.

You will collaborate cross-functionally to ensure product integrity, regulatory compliance, and continuous improvement initiatives, supporting audits and internal/external reviews.

Qualifications

• Degree or equivalent experience required; typically 4+ years of relevant experience.
• Strong written and verbal communication skills.
• Detail-oriented with ability to enter data accurately.
• Proficiency in Microsoft Word, Excel, and Outlook.

Responsibilities

• Monitor and manage daily quality operational workflows.
• Develop, implement, revise, and maintain quality standards, procedures, and work instructions.
• Identify and implement process improvements to enhance efficiency and reduce costs.
• Address and resolve operational quality issues, escalating complex problems as needed.
• Support calibration management, IMS reviews, and CAPA activities.

Skills

Communication

Clear written/oral communication

Detail-oriented

Data entry accuracy

Problem solving

Organizational skills

Education

Degree or equivalent experience

Tools

Microsoft Office

Job description

McKesson is seeking a quality systems professional to develop, implement, and maintain quality programs ensuring regulatory and client requirements are met. The role provides site-level QA oversight across operations, inspections, CAPA, temperature monitoring, and quality metrics.

You will collaborate cross-functionally to ensure product integrity, regulatory compliance, and continuous improvement initiatives, supporting audits and internal/external reviews.