Job Summary:

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

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 the expansion of services. We are specifically seeking an experienced Biomedical Technician who can provide mentorship and leadership in the development of our internal technical training program.

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

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 on-site 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 on-site and virtual QMS training to employees.

• Partner closely with the management team to foster a strong quality-driven culture, ensuring all 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.

• If less than 5 years of experience: a college degree and direct experience training other technicians, along with demonstrated knowledge of quality-related areas such as good documentation practices and process improvement.

• Working knowledge of accreditation agencies within the home health industry, including The Joint Commission (TJC), Accreditation Commission for Health Care (ACHC), and other regulatory agencies and standards such as FDA, Centers for Medicare & Medicaid Services (CMS), and ISO 13485:2016.

• Proven ability to manage multiple projects in a fast-paced environment.

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

Additional Knowledge & Skills

• Self-starter capable of working independently, exercising sound judgment, and proactively engaging support as needed to achieve objectives.

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

• Ability to collaborate effectively across functional teams and deliver results within a matrixed organizational environment.

• Proficiency in Microsoft Office applications, including but not limited to Excel, Access, PowerPoint, and Word.

Working Conditions

• 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.

• A home-based office may be considered for the right candidate.