Sr. Quality Engineer

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.

Key Responsibilities/ESSENTIAL FUNCTIONS

The Quality Engineer is expected to contribute to the following focus areas, depending upon assigned domains:

• Quality System Management: Consistent application of Quality System standards to operational processes including SOP development, document control, product quarantine, etc.
• Continuous Improvement: Proactively engaged in continuous quality improvement of MMS-GS operations.
• CAPA Management: Handle Corrective and Preventive Action (CAPA) processes.
• Validations and Qualifications: Including protocol development, execution, and record-keeping.
• Product Release: Oversight of kit packing, relabeling, rework processes, and final product release.
• Audit Preparation: Supports MMS-GS in maintaining the QMS including preparing audit-related document packages.
• Data Analysis: Use analytical methods and statistical techniques to support and/or measure performance, investigations, sample planning, improvements, corrective actions, preventive actions, implementations, and effectiveness.
• Trend Monitoring: Monitor for trends, escalations, and partner with sources of root causes to implement effective corrective actions that reduce non-conformances and risk in future shipments.
• Cross-Functional Engagement: Engage in process development, maintenance, improvement, and issue resolution. Participate in problem-solving activities of moderate scope and complexity.
• Project Participation: Participate and contribute to project meetings and working sessions.
• Supervisory Role: May need to assume the role of Quality Supervisor as needed.
• Customer Support: Flexible in supporting internal and external customers during extended hours.
• Travel: Travel as necessary to support quality and business projects.
• Production Facility Support: This role is based at a production facility and a flex working hours option may not be available.
• Other Duties: Perform other duties as assigned.

Qualifications for the Position:

• Education/Training
  • Science and/or Engineering Degree (Chemical, Biomedical, Industrial, etc.)
  • 2-5 years of commercial experience
  • Working knowledge of ISO13485/21 CFR 820, 211, and 210 preferred
• Business Experience
  • Experience with Microsoft Word, Excel, PowerPoint required.
  • Experience in document development (SOP, WI, Templates, Forms, etc.) preferred.
  • Quality Assurance experience in healthcare or other regulated industries preferred.
  • Must be able to effectively communicate in English (oral and written).

• Specialized Knowledge/Skills
  • Experience in document hierarchy execution is a plus.
  • Experience with SAP QM, Zavanta, Master Control, or another computerized document control system a plus.
  • Able to facilitate readiness and lead internal and external audits.

Additional Requirements

Must willing and qualify to become a designated representative for licensing and meet the following criteria:

• Have a minimum of two years of paid work experience in the past three years, related to the distribution or dispensing of dangerous drugs or dangerous devices in a licensed pharmacy, drug wholesaler, drug distributor, or drug manufacturer.
• At least 21 years old.
• Be a citizen of the United States with a state-issued ID/driver's license or passport.
• No disqualifying background history (minor traffic violations are acceptable).
• Boards will conduct background checks, and an FBI background check will be performed.
• Provide personal information as requested
• Must be actively involved in and aware of the actual daily operation of the facility.

Career Level: IC-Professional-P3

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. 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. For more information regarding benefits at McKesson, pleaseclick here.

Our Base Pay Range for this position

McKesson is an Equal Opportunity Employer

McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age or genetic information. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

Join us at McKesson!