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.

The Sr. Quality Engineer - Operations is a key member of McKesson Medical Surgical Quality & Regulatory Compliance Organization and will contribute towards McKesson's mission of improving healthcare in every setting. He or she monitors and drives compliance with regulatory, corporate and QMS policies and procedures. This role will report to the quality manager for East region and will execute short term & long-term initiatives to maintain QMS in a compliant state.

The location for this role is Urbancrest, OH and has the option to be located at McKesson sites in Richmond (VA), Bethlehem (PA) and Northborough (MA). The format of the role is remote hybrid role with 40% onsite requirement that includes 25% travel. This is mid- career role (P3) with growth opportunities.

Key Responsibilities:

• Act as a quality project manager for initiatives moderate to complex in scope and applies knowledge of quality regulations & principles, theories and concepts to standard work
• Independently work on problems of diverse scope where analysis of quality attributes & metrics requires evaluation of identifiable factors.
• Independently owns CAPAs from initiation to closure
• Must have demonstrated experience in situations where the development of the solution requires a multi-disciplinary approach
• Supports, MMSQRC organization in maintaining the QMS including preparing audit related document packages
• Actively contributes as a quality SME to assigned projects from initial kickoff to post marketing phase.
• Research & introduce de facto quality methods/procedures that are new for the organization. Applies advanced quality process & principles to multiple tasks. Eg. Kaizen or LEAN.
• Ensures that quality and operational requirements are defined, implemented, and monitored at the DCs per FDA QSR and in adherence to manufacturer quality agreements
• Promotes the awareness of quality, regulatory, customer and statutory requirements throughout the organization
• Publishes reports documenting errors and compliances issues and recommends potential solutions when appropriate.
• Regularly communicates with the Operations team to escalate issues and to recognize individual and team compliance
• Travel to support internal projects as required

Minimum Requirements:

4+ years of relevant experience

Critical Skills:

• Strong working knowledge of Quality Management Systems or similar
• Medical device and RX Drug knowledge
• Strong working knowledge of domestic regulations (Federal, State and Third Party)
• Experience speaking to the awareness of SOP's
• 2+ years of experience with Kaizen & Poka Yoke
• 2+ years of experience assessing business risks and developing mitigation strategy
• Global and distributed team experience in device/drug industry preferred
• Excellent written and verbal communication. Proven successful in communicating effectively with internal stakeholders, colleagues and external Regulators
• Must be flexible in supporting internal & external customers during extended hours

Education:

• HS Diploma or equivalent required:
• Bachelor's degree in Biomedical engineering or another STEM field with 5-7 years of related experience in quality and/or regulatory compliance preferred
• Graduate degree in quality or regulatory or ASQ/RAPS certification preferred

Physical Requirements:

• Desk and computer management
• Driving/Travel to distribution centers for the purpose of conducting audits

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. For more information regarding benefits at McKesson, please click here.

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. 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

McKesson is an Equal Opportunity/Affirmative Action employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.Qualified applicants will not be disqualified from consideration for employment based upon criminal history.

McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to [email protected]. Resumes or CVs submitted to this email box will not be accepted.

Current employees must apply through the internal career site.

Join us at McKesson!