Transforming the future of healthcare isn't something we take lightly. It takes teams of the best and the brightest, working together to make an impact.
As one of the largest healthcare technology companies in the U.S., we are a catalyst to accelerate the journey toward improved lives and healthier communities.
Here at Change Healthcare, we're using our influence to drive positive changes across the industry, and we want motivated and passionate people like you to help us continue to bring new and innovative ideas to life.
If you're ready to embrace your passion and do what you love with a company that's committed to supporting your future, then you belong at Change Healthcare.
Pursue purpose. Champion innovation. Earn trust. Be agile. Include all.
Empower Your Future. Make a Difference.
Title: Project Manager; Quality Communications
OVERVIEW OF POSITION
The Project Manager; Quality Communications is responsible for the overall management, planning and execution of activities to address safety, security, and technical concerns identified with installed products. Provides support for planning and communication of product recall activities, product updates, and other forms of customer communication, as needed. Performs ongoing management, tracking and monitoring of customer communications, and completion of any associated actions.
WHAT WILL BE MY DUTIES AND RESPONSIBILITIES IN THIS JOB?
- Leads and provides oversight to ensure that appropriate plans are generated within defined timelines, timely execution of all required activities and manages activities with cross-functional stakeholders, including product development, services implementation, customer success, and QARA, as required. Provides oversight to ensure the execution of all activities, and proactively escalates any activities not meeting expected timelines to management representatives.
- Ensures well-defined procedures are established, implemented, and supported by appropriate tools, that accurately describe the required planning, publishing, distribution, tracking and reporting activities for each advisory notice. Ensure all SOP's are followed and SLA's are adhered to as outlined
- Coordinates the initiation of recalls with QARA to ensure that applicable regulatory requirements are met and Manage activities, with the applicable departments and SME's, to identify and ensure the required resources are available to execute on recall activities, including personnel, replacement parts, and tools. Work with applicable SME's to prepare advisory notices and other communications, including FAQs and necessary training materials needed for customer-facing personnel including Support, Sales, and Sales Operations, as applicable.
- Establishes communication plans for the distribution of advisory notices to affected parties, including external organizations (distributors, resellers, government customers and cybersecurity monitoring entities).
- Establishes key relationships with third-party resellers and distributors to ensure that recall progress is gathered and reported in a timely manner. Ensures that recall progress is reported to the necessary stakeholders, including executive management, QARA, and teams responsible for implementing the identified corrective actions (Customer Success / Customer Operations), as defined in applicable SOPs.
WHAT ARE THE REQUIREMENTS NEEDED FOR THIS POSITION?
- Post-secondary degree or diploma in a related field, other related education by training or equivalent experience.
- 5+ years' experience in Quality of a high tech and application software industry with a minimum of 2 years in a project management role or cross-functional coordination role.
WHAT OTHER SKILLS/EXPERIENCE WOULD BE HELPFUL TO HAVE?
- Strong technical, organizational, troubleshooting and interpersonal skills.
- Strong project management skills.
- Collaborative and self-motivated team player.
- Able to interact constructively with other departments, their management teams, staff, and internal and external customers.
- Able to interact with and present to senior management.
- knowledge of medical device regulations and standards applicable to the Company's products, including:
ISO 13485 : 2016 Medical Device Quality System Requirements,
ISO 14971:2007 / EN 14971:2012 Medical Device Risk Management,
U.S. FDA Quality System Regulation (21 CFR 820), Medical Device Reporting (21 CFR 803), Corrections and Removals (21 CFR 806)
IEC 62304:2006 Medical Device Software Life Cycle Processes
Medical Devices Regulations (SOR/98-282), COUNCIL DIRECTIVE 93/42/EEC
What are the working conditions and physical requirements of this job?
General office demands
Join our team today where we are creating a better coordinated, increasingly collaborative, and more efficient healthcare system!