Technical Complaint Specialist

Company: SightSpectrum LLC
Location: Morrisville
Posted on: February 20, 2021

Job Description:

Hi, This is Saravanan from the staffing team of SIGHT SPECTRUM. we have an opportunity mentioned below, Role: Technical Complaint SpecialistLocation: RemoteDuration: Contract To HireJob Description:The position will be engaged in leading key aspects of Kymanox's service offerings and supporting clients covering post-market surveillance activities, compliance, and life cycle management challenges related to complex combination products (e.g., biologic-device, drug-device). Work under the guidance of Kymanox management and senior resources with support of multiple experienced technical project managers. Work closely with clients at their offices or remotely.Projects may include any of the following focus areas:

• Product Technical Complaints
• Deviation Investigations
• Root Cause Analysis
• Corrective and Preventative Actions
• Medical Device Design Controls (e.g., DHF support)
• Risk Management Files
• Process Improvement and Troubleshooting
• Data Analysis, Including Statistical Analysis
• Strong Technical Writing Authorship, Review, and Formatting
• Manufacturing and Complaint Investigations
• Quality Management Systems (QMS) SupportAdditional responsibilities can include:
  • Author technically simple and complex documentation to ensure technical
  • competence to relevant local and federal regulations.
  • Familiarity with risk management tools and applications
  • Familiarity with data analysis tools and applications
  • Others, as applicableDesired Aptitude and Skill Set:
    • Excellent written and oral English communication skills
    • Resourceful
    • Extremely detail oriented
    • Ability to work effectively with remote team members and/or direct reports
    • Highly organized
    • Self-directing, self-pacing
    • Understanding of own limitations
    • Ability to solicit and utilize subject matter expert input
    • Fast learner
    • Pleasant and positive communication style
    • Strong customer-service aptitude
    • Excellent problem-solving skills
    • Soft skills (i.e., high EQ)
    • Team player
    • Thrive in a fast-paced, growing, and dynamic work environment
    • Technology savvy Please let me know your availability at your earliest convenience. Regards,Saravanan P - provided by Dice

Keywords: SightSpectrum LLC, Cary , Technical Complaint Specialist, IT / Software / Systems , Morrisville, North Carolina