Quality Complaint Analyst

hace 3 semanas

Alcobendas, España Institut Straumann Ag A tiempo completo

About Straumann Group Headquartered in Basel, Switzerland, the Straumann Group stands at the pinnacle of dental innovation, with a reach spanning more than 100 countries worldwide. We pride ourselves on our expansive network of distribution subsidiaries and partners, showcasing global brands such as Straumann, Neodent, Medentika, DR SMILE, TeethToday, and more. Our mission: To revolutionize dental care, offering a wide range of products, solutions, and services, from dental implants and biomaterials to digital equipment and software.
Summary of position
Supports and implements systems in the areas of post market surveillance, complaint handling, and customer feedback. Supports the development of and enforces internal systems and procedures to meet ISO standards, FDA quality system regulations, and other regulatory requirements.
Essential functions and duties
• Receives customer complaints and review to determine validity of complaint.
• Request customer returned product and performs digital investigation.
• Collects relevant data about identified issues.
• Provide correction for customers where defects are present.
• Escalating valid complaints to the Quality Complaint Analyst II for probable cause investigation.
• Work in a team environment with members of the Post Market Surveillance group on achieving team metrics requirements.
• Work independently and with different parts of the organization to resolve complex issues.
• Identifies and assesses new opportunities for improvements to work processes.
• Able to prioritize workload to ensure maximum efficiency and customer satisfaction.
• Accurately records and reports of information as required.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. A reasonable accommodation may be made to ensure individuals with disabilities are able to perform the essential functions of the role.

• At least 5 year of medical device manufacturing.
• Understanding of ISO 13485, EUDMR, 21 CFR 820, and GDP.
• Documented ISO 13485 and 21 CFR 820 training
• High school diploma or GED is required
• Technical writing skills desired.
• Ability to work with multidisciplinary teams to execute projects, investigations, and training.
• Demonstrated ability to plan and work to robust timelines
• Excellent understanding of quality principles and good documentation practices.
• Experience in investigation techniques and problem solving.
• Must have excellent written communication skills.
• Must have basic computer skills (Microsoft Office).
This position is responsible for reporting of the following metrics on a regular basis:

• Complaint Accept Time
• Complaint Evaluation Time
• Number of Complaints Reported data
• Complaint Submission Type data
• Other reports and information as required.


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