Spacelabs Healthcare
Website:
spacelabshealthcare.com
Job details:
Overview
The Complaint Analyst is responsible for the evaluation, investigation, documentation, and regulatory assessment of product complaints associated with medical devices. This role supports compliance with applicable global regulations and quality system requirements through complaint investigations, adverse event reportability assessments, complaint trending, risk escalation, and cross-functional collaboration to identify and mitigate patient safety and product quality risks.
Responsibilities
- Independently conduct and document complaint investigations of moderate to high complexity by evaluating product performance concerns, gathering information from customers, users, field representatives, and internal stakeholders, reviewing service records and product analysis findings, and exercising sound judgment to determine complaint conclusions and appropriate escalation activities.
- Coordinate and review product analysis, service evaluations, engineering assessments, and event coding activities to support complaint investigations, facilitate product performance monitoring, and ensure consistent event categorization.
- Ensure complaint records are complete, accurate, and compliant with applicable procedures, regulatory requirements, and record retention requirements.
- Assess complaint events for regulatory reportability using established decision models and investigation findings, and support the preparation, review, and documentation of MDR, Vigilance, and other applicable adverse event reports.
- Review service records, service reports, and other post-market information to assess whether events meet complaint criteria and verify appropriate complaint classification in accordance with applicable procedures and regulatory requirements.
- Analyze complaint, service, and performance data to identify emerging quality, safety, reliability, or compliance trends and appropriately escalate issues requiring CAPA, risk management review, regulatory assessment, or other corrective actions.
- Participate in the review, validation, and continuous improvement of regulatory decision trees, complaint evaluation processes, and related complaint handling procedures.
- Compose clear and concise written communications detailing complaint events, investigation activities, product analysis findings, conclusions, and corrective actions, as applicable, for both internal and external use.
- Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork.
- Demonstrate behavior consistent with the company’s Code of Ethics and Conduct.
- It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
- Duties may be modified or assigned at any time to meet the needs of the business.
Qualifications
- Bachelor's degree in Engineering, Regulatory Affairs, Life Sciences, Nursing, Biomedical Engineering, or related discipline preferred. Equivalent combination of education and relevant experience will be considered.
- Demonstrated experience conducting complaint investigations, evaluating product performance issues, and documenting investigation conclusions in accordance with regulatory requirements.
- Fluency in English, with demonstrated ability to read, write, and communicate verbally at a professional level.
- Couple of hours of overlap with the snoqualmieteam who usually work between 7:30AM-5:30PM PDT.
- Experience evaluating adverse events and determining regulatory reportability using established decision trees and applicable regulatory requirements preferred.
- Demonstrated knowledge and practical application of ISO 13485, FDA medical device regulations, and ISO 14971 risk management principles.
- Knowledge of global medical device regulations and reporting requirements (e.g., EU MDR, UK MDR, Health Canada, TGA).
- Experience working within electronic Quality Management Systems (eQMS) and complaint management databases preferred.
- Must be able to perform critical thinking to identify and synthesize patterns from emerging trends and translate into actionable recommendations
- Strong technical written and verbal communication skills; ability to work effectively across all levels of a global organization and remain composed in urgent circumstances
- Must have ability to work in collaborative and independent work situations and environments with minimal supervision.
- Proficiency in multi-tasking and working in a high-paced, matrixed environment with an awareness of continued impact on compliance and operational performance
- Ability to effectively collaborate with cross-functional stakeholders including Regulatory Affairs, R&D, Service, Quality, and Supply Chain to support complaint investigations and risk mitigation activities.
- Ability to learn how to use the Spacelabs Healthcare products that are supported (training provided)
- Organized and resourceful with excellent attention to detail and ability to execute on assigned project plans.
Physical Requirements
Standing: 5% Bending:
Sitting: 80% Stooping: Reaching:
Walking: 10% Lifting: (0 – 25lbs)
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