What are the responsibilities and job description for the Quality Systems Technician position at HeartCentrix Solutions?
Job Details
Responsibilities:
- Prepare quality documentation and reports by collecting, analyzing, and summarizing information on failed processes, stability studies, recalls, corrective actions, and re-validations.
- Develop plans by conducting analyses, identifying critical control points and preventive measures, establishing monitoring and verification procedures, and implementing corrective actions.
- Review communications related to company equipment to determine if they qualify as complaints and assess potential reportability to regulatory agencies.
- Analyze equipment complaints to evaluate resolution status and identify necessary actions for unresolved issues.
- Document investigation steps and results accurately.
- Communicate with internal teams to investigate and resolve complaints.
- Adhere to all company policies, guidelines, and Standard Operating Procedures (SOPs).
- Escalate issues to supervisors as needed for resolution.
- Assist with assigned projects and tasks.
- Perform other duties as assigned.
Required Experience & Skills:
- Education: High School Diploma required.
- Experience: 0–1 year of related experience.
- Basic understanding of at least one company product line.
- Knowledge of fundamental dialysis concepts is a plus.
- Basic computer skills, including proficiency in databases, spreadsheets, and word processing programs.
- Strong oral and written communication skills.
- Exceptional attention to detail.
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