Global Complaints Analyst (Alajuela, Costa Rica)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. 

This position effectively supports the complaint handling process and processes complaints in a uniform and timely manner.  This position will act as the “single point” of contact between internal and external customers, Sales organization, HCPs, nurses and patients concerning products quality issues and complaint.

A person in this role: (i) evaluates incoming information concerning product complaints and enters available data into the Complaint Handling Database;  (ii) communicates with customers to request missing/additional information from the complainant and/or involved parties; (iii) updates the record when additional information is received; (iv) routes all the information for regulatory assessment and investigation; (v) reviews the complaint for completeness and accuracy before the closure of the complaint; (vi) communicates results of complaint investigation back to customers.

Under the direction of the Complaints Manager, this position manages activities and procedures associated with complaint communication. It is accountable for setting own work direction and completing work tasks. Other duties may be assigned at the direction of the corresponding Manager.

This position is a P1 level

What will you be doing?

Responsibilities

• Receives, reviews, and enters product complaint information into the complaint handling database and interacts with HCPs, Patients and the Sales organization regarding their Product Quality concerns.

• Continuously monitors the information gathering process and tracks the status of complaint communication until end customer communication. Continually track open, in process and complete complaints and product investigations and follow-up internally and externally.

What will you need to be successful?

Education:

• Bachelor’s degree in engineering (Industrial Engineering, Electromedicine Engineering, Biomedicine Engineering, etc.), Nursing, Biology or Microbiology, or another related discipline.

Experience:

• Relevant experience is preferred but not required. This may include academic projects, internships, technical training, or exposure to Quality Assurance and/or Compliance in a regulated environment.

Languages:

• Must be fluent in the English language, verbal and written.

Knowledge:

• Must be an intermediate user of MS Office Excel (filters, pivots), Word and PowerPoint.

• Knowledge of U.S. Food and Drug Administration, European Medical Device Directive (MDD), and International Medical Device Regulations and quality system regulations (including 21 CFR 803 & 820, MDR (Regulation (EU) 2017/745), and ISO 13485) (beneficial).

• Knowledge of complaint handling, adverse event reports and quality systems is beneficial.

Competences:

• Strong critical thinking, and problem-solving skills.

• Detail oriented.

• Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors.

• Must have the ability to work in a team environment and organized.

• Ability to work independently

• Strong feeling toward accountability.

• Ability to work with a diverse network of both internal and external groups and/or individuals.

Physical Demands:  Weight Lifting: Light (0kg - 5kg)

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. 

Inclusion + Belonging - Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/ 

• Your future:  stock purchase program, referral bonus, subsidy in transport and food, recognition program.

• Work/Life Balance: Extra days off, birthday off, voluntary hours.

• Your Wellbeing: company doctor, medical insurance, gym, health campaigns, employee assistance program, parental leave. 

• Flexibility: Hybrid work model (for more professional roles), flexible schedules.

• Training: Training program, unlimited learning.

• Extra perks: employees association, and more…

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