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Calyxo, Inc. logo
Calyxo, Inc.

Redefining kidney stone care

Complaint Analyst

AnalystAnalystOtherRemoteSeniorTeam 11-50Since 2016H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

139 days ago

Salary

$94K - $110K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

Complaint Analyst

Calyxo, Inc.

• Facilitate complaint investigations while ensuring completeness and consistency of complaint files/records. • Support post-market compliance activities including handling of customer complaints in accordance with documented procedures • Evaluate complaints and perform preliminary complaint investigation including follow up with healthcare professionals and sales representatives • Escalate complaints when encountering new failure modes, and partner with Engineering, Field Personnel, and Quality Assurance to investigate. • Ensure complaint documentation and records are complete in compliance with regulatory requirements • Coordinate complaint investigation efforts with Quality and R&D team driving investigations to completion in a timely manner • Collaborate with Customer Service, Regulatory, R&D, Manufacturing, Commercial, Medical and other functional areas to obtain/provide information related to complaint investigations and other aspects of complaint handling • Assist in updating Quality procedures as required through the change order process. • Maintain comprehensive records of customer interactions, complaints, and resolutions in the company's electronic Quality Management System • Support and participate in internal and external audits • Perform other duties as assigned by Quality Management

Job Requirements

  • Education: Bachelor of Science in Engineering, Technical or Life Science discipline or equivalent work experience preferred
  • Minimum 5 years of experience working in the medical device industry
  • Work location: Remote
  • Travel: Ability to travel up to 10%. Overnight domestic and/or international travel may be required
  • Working knowledge of FDA regulation, ISO 13485 and related ISO/EN standards.
  • Strategic yet hands-on when needed with a high degree of energy and drive, and the ability to seek function and process improvements continually.
  • Open and direct communication style and a vision for continuous improvement and excellence.
  • Experience with Class II and/or III sterile devices (preferred).
  • Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.

Benefits

  • A competitive base salary of $94,000 - $110,000 and variable incentive plan
  • Stock options – ownership and a stake in growing a mission-driven company
  • Employee benefits package that includes 401(k), healthcare insurance and paid vacation

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