Overview
The Complaint Coordinator is responsible for managing the Quality Affairs / Regulatory Affairs (QA / RA) queue.
Responsibilities
Administer case database with particular focus on product complaints
- Maintain integrity of cases and the complaint management process
- Report on designated case metrics at defined intervals
- Provide case analyses as requested by management
- Interface with various departments using case systems
Complaint Management
Review assigned cases within the QA / RA queue dailyAudit relevant case information and update required fields where necessaryInitiate communication and interaction cross-functionally regarding product complaintsEnsure all complaints are acknowledged and completed within the given timeframePerform regulatory closure of product complaint casesIdentify complaints that require escalation as a potential reportable event based on established criteria and applicable regulations and notify management within specified timeframeAssist with complaint related reporting activitiesAssist with preparation of required reports, e.g. MDR's, to external agenciesSupport departmental audits / reviews of conformance to applicable standardsOther duties as assignedQualifications
Education & Experience
Required :
Bachelor's degree or equivalent work experience1 years' experience handling customer complaints from receipt to closure, in regulated medical device industryPreferred :
Previous regulatory or quality experienceExperience analyzing medical device complaints and reporting on adverse eventsKnowledge & Skills
Strong proficiency in Microsoft Office Suite, including Word, Excel, Teams and PowerPointAbility to successfully manage multiple tasks at one timeAbility to utilize data from metrics and key data pointsFamiliarity with federal regulatory complianceUnderstanding of the business and products (Department processes and overall objectives)Ability to work independently and amongst a teamAbility to communicate effectively with employees at all levels of the businessStrong problem solving and critical thinking skillsHigh attention to detail and accuracyAbility to organize and plan activities that drive and meet deadlinesWorking knowledge of Filemaker and NetSuite Database structures or equivalentBelow is the starting salary range for this position, although offers may differ based on the candidate's location, job-specific knowledge, skills and experience.
23.41 - $30.69 / HR
Additional benefits :
non-exempt - Our total compensation package includes medical, dental and vision benefits, retirement benefits, employee stock purchase plan, paid time off, parental leave, family medical leave, volunteer time off and additional leave programs, life insurance, disability coverage, and other life and work wellness benefits and discounts. Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions.
Salary : $23 - $31
