Complaint Investigation Technician

Job description

Complaint Investigation Technician

Location: Leamington Spa

Smith & Nephew is a diversified advanced medical technology business that supports healthcare professionals in more than 100 countries to improve the quality of life for their patients.
We have leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma:
· Orthopedics Reconstruction - joint replacement systems for knees, hips and shoulders
· Advanced Wound Management - wound care treatment and prevention products used to treat hard-to-heal wounds
· Sports Medicine - minimally invasive surgery of the joint
· Trauma & Extremities - products that help repair broken bones
We have 14,000 employees around the world.

Annual sales in 2015 were more than $4.6 billion .

We are a constituent of the UK's FTSE100.


Where will this role sit?

This role will be based at the Smith & Nephew Site in Leamington Spa within the Complaint Management Group

Job Summary:

The Complaint Management group is focused on ensuring that Smith & Nephew complies with key Global international regulatory requirements, including: complaints processing, vigilance reporting, Post Market Surveillance, and supporting product safety assessments including Health Hazard Evaluations, Quality Holds and Field Action/Recall implementation.

Reporting to the SR Manager this role will be responsible for the investigation of devices and information supplied through the complaint management process, as well as the initiation of actions identified to improve device quality, reliability and customer experience.

What will the job involve?

This role will be responsible for the following key aspects:
· Performing the complaint investigation on customer complaints with and without products returned.
· Performing decontamination of devices prior to investigation according to company policy and procedures.
· Participating in risk analysis for all reported complaints (Triage).
· Evaluating and documenting the root cause of the failure as well as the complaint analysis under the elements of the global Quality System.
· Understanding products at site and various failure modes associated with these products.
· Communicating the results of the investigative analysis through written reports.
· Ensuring work is compliant with all appropriate laws and regulations.
· Applying engineering knowledge and logic to improve complaint handling processes to ensure smooth operation of the department.

Desired profile

Education and experience:
· Previous demonstrable experience within a similar technical role, within a regulated industry (preferably medical devices) or educated to degree level within a technical field or equivalent.
· Understanding of basic inspection techniques and problem solving skills
· Experience working in FDA, GMP and ISO environments is highly desirable.
· Proficient in Word and Excel, and good writing skill is needed. Experience in MS Access, MS Visio, Agile, and SAP desirable.
· Excellent interpersonal / communication skills, both written and verbal.
· Highly flexible and adaptable; ability to multitask.
· Ability to interpret diverse regulations and drive/influence effective implementation.
· Ability to keep a positive mind-set whilst working within a challenging work environment.