Product Risk Specialist - Medical Device Software - Risk Management job
McKesson Technology Services - Alpharetta, GA

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Agency Statement No agencies please Benefits Company Statement We believe you should be rewarded for the important work you do For that reason youll receive a competitive compensation and benefits package when you join our team It starts with you Thats 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 were helping to ensure that millions of patients get the treatment they need And by choosing a career with McKesson Provider Technologies youll 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 mckessoncomcareers Physical Requirements General Office Demands CertificationsLicensure ASQ Quality Certification desired Education Bachelors degree in an applicable science engineering or technical field OR a twoyear degree plus significant medical device in a Quality Assurance role preferred Additional Knowledge Skills Extensive Product Risk experience in the Medical Device Software industry Experience working with Clinical Information Systems or Healthcare Software Solutions also desirable Minimum Requirements 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 149712007 Medical Device Risk Management US FDA Quality System Regulation (21 CFR 820) IEC 623042006 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 knowledgeexperience 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 Position Description 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 MPTs 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 (eg 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 andor present quality reports data and key performance indicators for management reviews Work with Product Management and RD 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 (eg 510ks) 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 The material contained herein is provided for informational purpose only All open jobs offered by McKesson Corp on this recruitment system are subject to specific job skill requirements The job skill requirements qualifications and preferred experience are determined by a subsidiary office or department within the company which is offering the position and all positions are subject to local prevailing employment laws and restrictions This would include immigration laws pertaining to work authorization requirements and any other applicable government permissions or compliance The materials on this site are provided without warranties of any kind either expressed or implied including but not limited to warranties regarding the completeness of information contained on this site or in any referenced links While McKesson Corp attempts to update this site on a timely basis the information is effective only as of the time and date of posting By providing your application to McKesson Corp you hereby consent to McKesson Corp obtaining personal information regarding you that is related to the position applied for You also consent to McKesson Corp transferring your application details to our recruitment partners for their review and assistance You also consent to McKesson Corp keeping your application on file for 6 years McKesson Corp is an equal opportunity employer The information on this site is for information purpose only and is not intended to be relied upon with legal consequence - 2 years ago - save job