Complaint & Quality Management Systems Analyst

1 month ago

Mesa, United States BioLab Holdings, Inc. Full time
Description

Position Overview:
We are seeking a detail-oriented and analytical Complaint and Quality Management Systems (QMS) Analyst to join our Quality Assurance team. In this role, you will be responsible for managing customer complaints and supporting the overall QMS to ensure compliance with regulatory requirements and continuous improvement of our products and processes.

Key Responsibilities:

1. Complaint Management:
    • Receive, log, investigate, and document customer complaints related to tissue products.
    • Perform containment actions as needed relevant to complaint products.
    • Escalate any reportable conditions and execute additional reporting as required
    • Analyze complaint data to identify trends, root causes, and opportunities for improvement.
    • Collaborate with cross-functional teams to ensure timely resolution and effective communication with customers.
2. Quality Management Systems (QMS):
    • Assist in the development, implementation, and maintenance of the QMS in accordance with industry standards (e.g., ISO 13485, FDA regulations).
    • Ensure all quality documentation is up to date and compliant with regulatory requirements.
3. CAPA Management:
    • Coordinate CAPA records and process in response to complaints and quality issues, including ensuring owners meet timely completion and closure.
    • Assist in training individuals on CAPA workflow and execution steps within QMS.
    • Assist and review root cause analysis to ensure investigation is sufficient and appropriate.
4. NCR and Product DispositionManagement
    • Coordinate the Nonconformance Response process for initiation, proper documentation, MRB approval, and resolution of quality issues and material dispositions.
    • Ensure containment actions are executed and documented for all impacted items.
    • Guide, monitor, and support personnel in investigations and nonconformance reports.
    • Responsible for ensuring all records are monitored and closed timely.
5. Data Analysis and Reporting:
    • Prepare and analyze reports on complaints, CAPA effectiveness, and other quality metrics for management review.
    • Provide insights and recommendations based on data analysis to drive continuous improvement initiatives.
6. Regulatory Compliance:
    • Ensure compliance with relevant regulations and standards throughout the complaint handling and QMS processes.
    • Assist in internal and external audits related to quality management and complaint handling.
7. Training and Support:
    • Provide training to staff on complaint handling procedures and QMS practices.
    • Support cross-functional teams in understanding and implementing quality standards.
8. Continuous Improvement:
    • Identify opportunities for process improvements and contribute to quality initiatives within the organization.
    • Participate in quality improvement projects as needed.
Qualifications:
  • Bachelor's degree in Quality Assurance, Life Sciences, Engineering, or a related field.
  • 5+ years of experience in quality assurance, complaint management, or QMS, preferably in the medical device, biotech, or tissue banking industry.
  • Strong knowledge of regulatory standards and quality management systems (e.g., ISO 13485, FDA regulations).
  • Excellent analytical skills and attention to detail.
  • Strong communication and interpersonal skills, with the ability to work collaboratively in a team environment.
  • Proficiency in data analysis tools and software.

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