Complaint Process Owner Connected Care

3 weeks ago

Indianapolis, Indiana, United States BioSpace, Inc. Full time
Job Title: Complaint Process Owner Connected Care

At BioSpace, Inc., we are dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at BioSpace, please complete the accommodation request form for further assistance.

About the Role:

We are seeking a highly skilled Complaint Process Owner Connected Care to join our team. As a key member of our Quality team, you will be responsible for implementing and supporting complaint handling processes and interfaces to design and change control processes and associated activities for connected medical devices and drug/device combination products (Connected Care Systems and MMAs (Mobile Medical Applications)).

Key Responsibilities:
  • Establish and maintain a Quality and contractual system with external service providers to provide front line customer support and execute technical troubleshooting and complaint investigations for Lilly's connected devices.
  • Provide Quality oversight for quality system activities performed by external contract service providers.
  • Lead implementation and maintenance of the customer support and quality system for connected devices and stand-alone SaMD (Software as Medical Device).
  • Drive product and process improvements through data obtained through complaint trending activities.
  • Review/write/approve GMP documents including technical reports, deviations/events, procedures, and work instructions.
  • Review and approve complaint investigations associated with use, design, contract manufacturing investigations for connected devices and drug/device combination products.
  • Lead onboarding and training of contract partners and implementation of connected product complaint process. Mentor, coach and provide feedback to external contract partners including participation in organizational planning.
  • Maintain key product and process metrics reporting the performance of the connected device customer support quality system to management with executive responsibility.
  • Network within and outside of IDM to identify and implement opportunities for improvement and/or transfer of IDM or complaint handling Best Practices for connected products to other business partners.
  • Collaborate with and provide customer service for groups external to IDM. Participate in meetings and teleconferences with Contract Partners, US and OUS Affiliates, Global Patient Safety, Americas' Regional Center, DPEM, Material Suppliers, and TLAC/external customer service providers, as applicable, to share technical and complaint process knowledge and to support investigations as needed.
  • Participate in or lead collaborative projects between the Complaint Regional Centers, Lilly Affiliates, Global Patient Safety, TLAC, and external contract partners. Implement applicable requirement from LQS, GQS, SEQS, CIQS quality policies for connected products. Ensure compliance with Medical Device Reporting (MDR) requirements for connected products.
  • Provide internal and external contracted complaint and customer service centers with complaint investigation procedures and Training/Knowledge Assessments for all connected devices as required in support of an established complaint triage strategy
Requirements:
  • Bachelor's Degree required.
  • Minimum of two years of life science, engineering or related industry experience in areas which may include Quality, MS&T, LRL, Development or Manufacturing/Packaging, Technical Customer Service, or Change Management. Experience with connected products would be an additional benefit.
  • Technical knowledge in design, manufacturing, or validation in the area of medical devices or combination products.
  • Technical knowledge of complaint handling and associated quality systems; preferably electronic and/or connected devices performance; technical knowledge/experience with medical device risk management
Preferred Skills:
  • Demonstrated leadership ability and experience with cross functional teams
  • Knowledge of applicable regulatory requirements (e.g. cGMP, 21 CFR 820, ISO13485, ISO14971, applicable regulations for Canada, US, EU, Australia, Brazil and Japan)
  • Experience with external parties/supplier/consultant interactions
  • Excellent oral and written communication
  • Basic knowledge in statistics and its applications
  • Ability to compile data and metrics in reports understandable by management and business partners
  • Strong computer literacy in technical GMP compliant computer systems and Microsoft Office applications
  • Attention to detail; self-management; problem solving; mentoring

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly

  • Complaint Resolution Manager

    11 hours ago

    Indianapolis, Indiana, United States Franciscan Health Full time

    As a Complaint Resolution Manager at Franciscan Health, you will oversee the daily operations and implementation of strategic and operational plans for assigned clinics. Your role will involve providing management oversight, supervision, and direction to customer service, sales, and billing and operations staff.Key responsibilities include:Managing a busy...

  • Customer Service Representative

    3 weeks ago

    Indianapolis, Indiana, United States Connected Staffing Solutions Full time

    Job DescriptionAt Connected Staffing Solutions, we are seeking a skilled and empathetic Customer Service Representative to provide top-notch support to our clients. The ideal candidate will have strong communication skills and a genuine desire to help others. No prior experience is required, as we offer comprehensive training and a ramp-up period to ensure...

  • Owner-Operator Van Truckload Driver

    4 days ago

    Indianapolis, Indiana, United States Schneider Full time

    Unlock Your Earning PotentialSchneider FreightPower offers owner-operators unparalleled access to a diverse range of freight, empowering you to choose from a variety of loads and revenue structures. With our platform, you can select from:All-In Revenue: Enjoy a hassle-free experience with loads featuring an all-in rate, eliminating the need for fuel and...

  • Senior Product Owner, SFMC

    2 weeks ago

    Indianapolis, Indiana, United States Humana Full time

    About the RoleWe are seeking a highly skilled Senior Product Owner to join our Marketing Regulatory and Operational Communications (MROC) team. As a Senior Product Owner, you will play a critical role in supporting Humana's marketing journeys, campaigns, and communications with business strategy and consulting on marketing and communication delivery...

  • Product Owner

    4 weeks ago

    Indianapolis, Indiana, United States Onebridge Full time

    About the RoleWe are seeking a highly skilled Product Owner to join our innovative team at Onebridge, a leading consulting firm with a strong presence in the US and beyond. As a Product Owner, you will play a critical role in driving cutting-edge ML/AI solutions that meet the evolving needs of our clients.Key ResponsibilitiesPartner with business...

  • Clinical Process Management Director

    5 days ago

    Indianapolis, Indiana, United States BioSpace, Inc. Full time

    Job Title: Associate Director, Clinical Process ManagementAt BioSpace, Inc., we are dedicated to delivering innovative solutions that transform the way we work. We are seeking an experienced Associate Director, Clinical Process Management to join our team.About the Role:The Associate Director, Clinical Process Management will be responsible for designing,...

  • Connected Vehicle Technician

    2 days ago

    Indianapolis, Indiana, United States IndyGo Full time

    Job Title: Connected Vehicle Technician IIndyGo is seeking a skilled Connected Vehicle Technician I to join our team. As a key member of our Intelligent Transit System team, you will be responsible for the installation, troubleshooting, maintenance, salvage, and inventory of our vehicular hardware and software components.Key Responsibilities:Monitor and...

  • Connected Vehicle Technician

    5 days ago

    Indianapolis, Indiana, United States IndyGo Full time

    Job Title: Connected Vehicle Technician IIndyGo is seeking a skilled Connected Vehicle Technician I to join our team. As a key member of our Intelligent Transit System team, you will be responsible for the installation, troubleshooting, maintenance, salvage, and inventory of our vehicular hardware and software components.Key Responsibilities:Monitor and...

  • Technical Product Owner

    4 weeks ago

    Indianapolis, Indiana, United States Moser Consulting Full time

    About Moser ConsultingMoser Consulting is a leading provider of IT talent with a strong focus on delivering exceptional results. With over 25 years of experience, we have built a reputation for taking great care of our clients, employees, and partners.We are committed to creating a work environment where employees can thrive and do their best work. Our...

  • Product Owner

    3 weeks ago

    Indianapolis, Indiana, United States One Bridge Inc Full time

    About the RoleWe are seeking a highly skilled Product Owner (AWS Glue) to join our innovative team at Onebridge Inc. As a Product Owner, you will be responsible for partnering with business partners to create and drive solutions, taking a progressive approach to understanding business impacts, quantifying resources, and evaluating/recommending technical...

  • Technical Product Owner

    3 weeks ago

    Indianapolis, Indiana, United States Moser Consulting Full time

    About Moser ConsultingMoser Consulting is a leading provider of exceptional IT talent with a proven track record of delivering innovative solutions to technology problems. Our people are our #1 asset, and we focus on giving them an incredible work space, a fun, collaborative, and creative atmosphere, an extremely generous compensation package, and dozens of...

  • Connected Vehicle Technician

    4 weeks ago

    Indianapolis, Indiana, United States IndyGo Full time

    Job SummaryWe are seeking a skilled Connected Vehicle Technician to join our team at IndyGo. As a key member of our Intelligent Transit System team, you will be responsible for the installation, maintenance, and troubleshooting of our vehicular hardware and software components.Key ResponsibilitiesMonitor and maintain the Intelligent Transit System (ITS)...

  • Product Owner

    4 days ago

    Indianapolis, Indiana, United States One Bridge Inc Full time

    About the RoleWe are seeking a highly skilled Product Owner (ML/AI) to join our innovative team at Onebridge Inc. As a key member of our organization, you will be responsible for partnering with business partners to create and drive cutting-edge ML/AI solutions.Key ResponsibilitiesPartner with business partners to understand business impacts and develop...

  • Veterinarian: Emergency Care Specialist

    4 weeks ago

    Indianapolis, Indiana, United States Veterinary Specialty & Emergency Care Full time

    About the PositionWe're seeking a compassionate and skilled veterinarian to join our team at Veterinary Specialty & Emergency Care. As a key member of our emergency care team, you'll provide exceptional care to pets and their families in a fast-paced and dynamic environment.Our ideal candidate is a motivated and empathetic individual who is passionate about...

  • Print Center Operator

    4 days ago

    Indianapolis, Indiana, United States Canon Business Process Services Full time

    Job SummaryWe are seeking a highly skilled and detail-oriented Print Center Operator to join our team at Canon Business Process Services. As a Print Center Operator, you will be responsible for providing exceptional customer service and solutions for clients' copy/print needs.Key ResponsibilitiesReview, prioritize, and submit print requests from...

  • Senior Business Analyst

    1 day ago

    Indianapolis, Indiana, United States Indiana University Health Full time

    At Indiana University Health, we're seeking a highly skilled Senior Business Analyst to join our team as a Product Owner. In this role, you'll be responsible for organizing, prioritizing, and assessing work for a scrum team, as well as acting as an ambassador to customers.Key Responsibilities:Act as a liaison between IT and business units for the...

  • Business Process Architect

    4 weeks ago

    Indianapolis, Indiana, United States BioSpace, Inc. Full time

    About the RoleWe are seeking a highly motivated and experienced Business Process Architect to join our team at Lilly. As a Business Process Architect, you will play a critical role in providing integration between business resources and IDS, influencing processes, tools, and operating models.Key ResponsibilitiesCollaborate with management and business...

  • Sterile Processing Technician in Valparaiso

    4 weeks ago

    Indianapolis, Indiana, United States ACES Healthcare Staffing Full time

    Exciting Opportunity for Sterile Processing TechniciansAbout the Job:ACES Healthcare Staffing is seeking highly skilled Sterile Processing Technicians to join our team in Valparaiso, IN. As a Sterile Processing Technician, you will play a crucial role in ensuring the highest standards of patient care by maintaining and processing medical equipment and...

  • Home Based Therapist

    3 days ago

    Indianapolis, Indiana, United States Family Community Connections LLC Full time

    Job TitleFamily Community Connections LLC is seeking a highly skilled Home Based Therapist to provide intensive support and intervention for youth and families.Key Responsibilities:Provide psychosocial assessments to determine eligibility/level of care to individuals using variety of assessment tools and methodologiesConduct trauma-focused assessments and...

  • Business Process Analyst Internship

    3 weeks ago

    Indianapolis, Indiana, United States Lumen Inc Full time

    About LumenLumen is a leading provider of digital innovation solutions, connecting people, data, and applications with speed, security, and ease. Our mission is to empower our people and help them reach their full potential, driving long-term success for both Lumen and our customers.The RoleWe are seeking a highly motivated and detail-oriented Business...