QA Complaint Analyst III

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 a wide range of complaint and failure analyses for all assigned product lines, requiring application of logic, understanding of general and specialized laboratory methods, techniques, and instruments. May coordinate the activities of others as assigned. May assist others in reviewing closures written by QA Complaint Analyst I or II.

Key Accountabilities

Essential Functions:

• Understands the application of the scientific method to experimental design and problem solving. Applies knowledge and experience to investigate and understand complaint information.
• Communicates results, problems, and progress to supervisor.
• Schedules investigative activities in accordance with assignments and priorities from supervisor.
• Detects problems in routine procedures caused by instrument difficulties, or in reagent preparation and/or handling. Suggests modifications/solutions in protocols and/or methods.
• Schedules and performs specific tasks, stability monitoring testing and analyzes data. Provides higher level input in the interpretation of data. Collates results, prepares reports and assesses progress relative to objectives.
• Handles broad assignments and objectives involving multiple tasks. Able to apply experimental design principles.
• Able to handle complex investigations, provide appropriate assessments and write accurate reports in a timely manner.
• Performs other related duties as assigned .

Secondary Functions:

• Contributes to the Department goals and is a team player.
• Understands the FDA, ISO, and Worldwide standards to which the complaint system must comply.
• Achieves broader professional judgment and experience through periodic training and continuing scientific literature review.

Internal Networking/Key relationships

To be determined based on department needs

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

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 NAtalentacquisition@werfen.com 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