QA Complaint Analyst II

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.  We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

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.

The annual base salary range for this role is currently $80,000 to $95,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

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 related field
• Two years of relevant experience

International Mobility: Required:

• No

Travel Requirements:

• No

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. 

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [email protected] for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com