QA Complaint Analyst III

Position Summary:

Performs wide range of failure analysis tasks for product quality complaints which requires the application of logic, understanding of general and specialized laboratory methods, techniques and instruments.

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

Minimum Knowledge & Experience required for the position:

• Bachelor's degree in a related field
• Five years relevant experience

Additional Skills & Capabilities:

• Computer proficiency including MS Office programs. Knowledge of basic statistics.
• Demonstrates hard and soft oral and written communication skills and ability to interact with various functional groups.

Travel requirements:
N/A