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Biomed Quality Specialist

Why This Role Matters

This is a unique opportunity to step into a highimpact role at a pivotal moment for McKesson BioMed. As our organization continues to expand the scope of medical devices we support were looking for a seasoned biomedical professional who is excited to help shape the future of our training quality and technical standardsnot just maintain what already exists.

Job Summary

In this role the Quality Specialist will drive regulatory and ISO compliance across the Biomed Solutions business. This individual will conduct both onsite and virtual assessments to identify improvement opportunities that may require intervention and remediation planning ensuring successful outcomes during ISO FDA or external audits.

We are specifically seeking an experienced Biomedical Technician who brings broad medical device experience and can provide mentorship and leadership in the development of our internal technical training program as the organization expands beyond its current device portfolio.

McKesson BioMed currently supports a core portfolio of medical devices including infusion pumps feeding pumps and ventilators. While experience with these devices is important preferred candidates will bring broader medical device experience and be able to help expand the organizations device footprint by establishing training competencies and quality standards that support growth into additional medical technologies.

In addition this role supports the McKesson BioMed business through ongoing mentorship and engagement helping Biomed Depots and Field Service teams consistently operate within McKesson standards for compliance and quality service delivery. This work is critical to enabling continued growth and expansion of services.

Growth Development & Career Path

Were seeking someone who is invested in this role and also excited about longterm growth. This position offers exposure across BioMed operations quality systems and enterprise initiatives opening pathways toward leadership roles within BioMed broader Quality organizations or other areas across NewCo/McKesson.
This is a role where your experience will be valued todayand your potential supported tomorrow.

Travel

• Up to 50% travel to Biomed Center locations and customer sites.

• Traditional home office environment.

• Preference for proximity to an existing Biomed Center in Jacksonville FL; Los Angeles CA; Chicago IL; or Pittsburgh PA.

Responsibilities

• Participate in and take ownership of executing and monitoring the Quality Management System (QMS) including CAPA complaints document control training ISO internal audits recalls and all other components of an ISO 13485 Quality System.

• Conduct onsite and virtual assessments to identify compliance gaps and improvement opportunities that may require intervention and remediation planning to support successful ISO FDA or external audit outcomes.

• Ensure compliance with all applicable regulatory requirements and McKesson Quality Management System standards.

• Mentor Biomed and Field Service teams to drive rapid transformation toward meeting and exceeding established McKesson performance and quality metrics.

• Deliver onsite and virtual QMS training to Biomed and Field Service employees.

• Partner closely with the management team to foster a strong qualitydriven culture ensuring employees understand the importance of quality in their daily work.

Minimum Requirements

• 4 years of relevant experience

• Ability to travel up to 50% to Biomed Center locations and customer sites

Critical Specialized Skills

• 4 years of experience in the medical device service industry related to preventive maintenance calibrations and repair of biomedical equipment.

• Preferred experience supporting a broad range of medical devices beyond infusion pumps feeding pumps and ventilators with the ability to translate that experience into scalable training programs competency frameworks and quality standards that support expansion into additional medical technologies.

• Direct experience training other technicians along with demonstrated knowledge of qualityrelated areas such as good documentation practices and process improvement strongly preferred.

• Working knowledge of accreditation and regulatory agencies including The Joint Commission (TJC) Accreditation Commission for Health Care (ACHC) FDA Centers for Medicare & Medicaid Services (CMS) and ISO 13485:2016.

• Proven ability to manage multiple projects and competing deadlines within a fastpaced environment.

• Excellent verbal written and presentation skills with the ability to communicate clearly and tailor messaging to diverse audiences.

Additional Knowledge & Skills

• Selfstarter capable of working independently exercising sound judgment and proactively engaging support as needed.

• Strong service mindset with a passion for helping Biomed teams succeed by removing barriers providing guidance and setting high performance standards.

• Ability to collaborate effectively across functional teams within a matrixed organization.

• Proficiency in Microsoft Office applications including Excel PowerPoint Word and related tools.

Working Conditions

• Up to 50% travel to Biomed Center locations and customer sites where walking throughout those facilities and extended periods of standing will be needed

• Remaining time spent working from home-based office at a computer

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 McKessons 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

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