QA Complaint Analyst II

Key Accountabilities

Essential Functions:

• Performs moderately complicated failure analysis assignments requiring specialized knowledge of sensors, instruments and hospital routines.
• Has the computer skills and instrument/cartridge knowledge necessary to analyze sensor or instrument complaints.
• Has instrument/system knowledge necessary to distinguish different types of failure mechanisms.
• Routinely communicates results, problems, and progress to supervisor. 
• Determines appropriate root cause for individual failures, select investigation results and conclusions from available templates, and recognize when a failure is atypical.
• Applies knowledge and experience to resolve a variety of investigation issues.
• Communicates results, problems, and progress to supervisor. 
• Schedules own investigation activities in accordance with assignments and priorities.
• May help to coordinate investigation activities with other team members or with other departments.
• During routine investigations detects problems caused by instrument or cartridges and alerts co-workers and supervisor. 
• Understands pre-analytical sample handling variables and correct operating procedures and techniques for required Acute Care Diagnostics or Hemostasis analyses and how these influence the results. 
• Collates investigation results, plots trends and prepares brief reports as required.
• Maintains accurate, precise, and legible laboratory notebooks if any follow-up experiments are required during the course of complaint investigations. 
• Able to handle broad assignments and objectives involving multiple tasks.
• Contacts may be primarily within the immediate organization. 
• Able assist in training new employees.
• Able to recommend/develop training tools and templates for routine complaint investigations.
• Performs other related duties as assigned.

Secondary Functions:

• Understands the FDA, ISO and Worldwide standards to which the complaint system must comply.
• Able to assist in training new employees.

Budget Managed (if applicable):

• N/A

Internal Networking/Key Relationship:

• To be determined based on department needs

Skills & Capabilities:

• Strong skills with Excel required
• Good writing skills to support documentation of investigation work.
• Knowledge of hospital lab practices preferred reagent/sensor, system development experience is beneficial.

Competencies:

• Attention to Detail: Ability to pay close attention to detail is required
• Accuracy: Work is accurate and complete
• Performance Standards: Demonstrated ability to meet department goals
• Communication: Excellent writte, verbal and presentation skills
• Discretion: Acts with integrity in all situations and can maintain appropriate confidentiality
• Multi-Tasking: Ability to manage multiple priorities, and support changing business needs
• Collaboration: Ability to work within a team to bring best soluitons to the team or customer
• Independence: Self-motivated-works under minimal supervision
• Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties
• Takes Initiative: Serves as a role model for "Quality First" by continuously improving on what matters most to customers
• Problem Solving: Promptly and effectively handles issues and problems
• Decision Making: Makes decisions based on data and risk determination