Product Risk Specialist Medical Device Software
McKesson 1,245 reviews - Alpharetta, GA

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Healing the healthcare system starts with you. It starts with the chain of events you initiate when you work with McKesson Provider Technologies - a chain that extends across the country and results in millions of people getting more from their healthcare.

McKesson Provider Technologies d

elivers comprehensive solutions with the power to change the way healthcare is provided. Our capabilities extend beyond healthcare IT software to include automation and robotics, business process re-engineering, analytics and other services that connect healthcare providers, physicians, payors and patients across all care settings. Over 50 percent of U.S. hospitals use our solutions on a daily basis. We're also a leader in solutions that manage complex financial information and optimize resources and supply chain management. Ultimately, we're helping the system run smoother so that healthcare works for all of us.

The Product Risk Specialist will be responsible for supporting the implementation and maintenance of a quality system for FDA class I and II medical devices. Candidate will be responsible for supporting procedure development, auditing, CAPA system administration and document control functions.

Candidate will help assure the quality system processes are streamlined and integrated with other McKesson Provider Technologies (MPT) business processes, suitable for MPT's broad range of products and services, and effectively prevents, identifies and resolves quality issues

  • Develop, implement, and maintain Quality System processes to meet the requirements of US FDA (e.g., 21CFR 820 QSR), ISO 13485), and other applicable quality and regulatory standards. This includes the development of procedures for design input, review, output, verification, validation, change control, management review, document control, CAPA, risk management and the audit processes.
  • Monitor the performance of the quality system processes, and recommend improvements to ensure effective processes are integrated with other McKesson Provider Technologies business processes.
  • Prepare and/or present quality reports, data, and key performance indicators for management reviews.
  • Work with Product Management and R&D to develop product regulatory strategy; monitor plans to ensure compliance to this strategy. Ensure product budgets include funds for submissions.
  • Ensure the compilation of device master records, design history file, device history records, and quality system and complaint records.
  • Participate on product design teams to ensure regulatory compliance in alignment with Quality System and Product Life Cycle Management.
  • Prepare or participate in the preparation of timely regulatory submissions (e.g., 510[k]s).
  • Provide regular updates to the Director, Quality and Regulatory Affairs regarding product regulatory status and global regulatory requirements.
  • Develop product risk management plans. Facilitate and /or participate in the development and maintenance of Product hazard Analysis.
  • Maintain awareness of global regulatory legislation and assesses its impact on business and product development programs. Identify risk areas and participate in the development of alternative courses of action and contingency plans.
  • Guide and influence technical groups in areas of product development, labeling and promotion. Evaluate labeling and promotional materials for regulatory impact and to ensure compliance with applicable regulations.
  • Develop regulatory training and provide training to support to stakeholder departments.
  • Participate in failure investigation (complaint and safety issues) and escalate potential adverse events, recalls, etc.
  • Participate in initial supplier approval and the continuing evaluation of supplier performance.
  • Plan, coordinate and execute internal / external audits.
  • Introduce and utilize appropriate quality tools to evaluate product and process performance such as, Pareto Charts, Risks Analysis and process maps.
  • Evaluate new or revised product against regulatory submission thresholds. Complete Product Evaluation Artifacts.
  • 8+ years experience in a Quality Assurance, preferably in a Medical Device Software environment.
  • Product Risk experience working with product development teams responsible for the design and development of Medical Device Software (hardware and software specs).
  • Knowledge of Medical Device regulations and standards applicable to HSES products, including: ISO 14971:2007 Medical Device Risk Management, U.S. FDA Quality System Regulation (21 CFR 820),
IEC 62304:2006 Medical Device Software Life Cycle Processes and HIPAA.
  • Experience developing Product Risk Management Plans, Procedures and Reports; establishing and maintaining the Product Risk Management File
  • Strong knowledge/experience with quality systems implementation and maintenance in an FDA regulated environment
  • Familiarity with automated QMS tools
  • Ability to analyze data and experience with tools such as Microsoft Excel or SQL.
  • Demonstrated excellent written and oral communication skills
  • Strong interpersonal skills
  • Conflict resolution skills
  • Ability to work independently, as well as part of a diverse team
  • Ability to set and meet aggressive timelines
  • Extensive Product Risk experience in the Medical Device Software industry.
  • Experience working with Clinical Information Systems or Healthcare Software Solutions also desirable.
Bachelor's degree in an applicable science, engineering or technical field OR a two-year degree plus significant medical device in a Quality Assurance role preferred

ASQ Quality Certification desired

General Office Demands

We believe you should be rewarded for the important work you do. For that reason, you'll receive a competitive compensation and benefits package when you join our team.

It starts with you. That's a simple sentence but it says a lot. It reminds each one of us that what we do matters. Every single McKesson employee contributes to our mission - whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe. By connecting and improving the business of healthcare, we're helping to ensure that millions of patients get the treatment they need. And by choosing a career with McKesson Provider Technologies, you'll join a team of passionate people working together to improve lives and advance healthcare.

At McKesson, we believe we can empower healthcare. And it all starts with you.

As an equal opportunity employer, McKesson Corporation unites the talents and contributions of all to advance the power of healthcare. Learn more about our opportunities at

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About this company
1,245 reviews
McKesson Corporation, currently ranked 11th on the FORTUNE 500 list, is a healthcare services and information technology company dedicated...