Medical Device Complaints Investigator 12 Month FTC
Smith and Nephew is focused on ensuring that it 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.
This position is responsible for investigation of devices and information supplied through the complaint management process, as well as initiation of actions identified to improve device quality, reliability and customer experience.
With full training provided this role is ideal for medical and scientific graduates/equivalent looking to secure 12 months' work experience.
Essential Job Functions
Performs complaint investigations to identify the root cause of alleged product failure and accurately document the complaint analysis in the complaints system. Failure investigation may include visual and photographic assessment of product condition, functional testing or the disassembly of returned device(s) in order to isolate the source of failure and make a definitive root cause analysis.
- Analyzes data and draw conclusions based upon the available information from the investigation and documents findings (including medical investigations) in complaint reports in the complaint handling system in an applicable manner for the customer completed in a timely manner.
- Conducts and controls shipping logistics of sending and receiving parts to and from the supplier respectively, and also to internal sites for further evaluations. Receives information from the supplier and updates the complaint handling system with the information. Works with suppliers for timely completion of investigations and other action items assigned to them.
- Works closely with medical advisor(s) and medical investigation team to quantify risk.
- Support legal department as required
- Acts as point of contact for Research & Development, Marketing, Logistics, Regulatory Affairs, Quality, Operations and external bodies such as appointed experts in their support of investigations related to the complaint management process.
- Provides updates on complaint investigation status
- Generates signals for containment and communicates with appropriate personnel on site to request corrective and preventive measures in cooperation with the Quality department through the CAPA system, as necessary.
- Supports Health Hazard Evaluation for suspected adverse incidents.
- University Degree level or equivalent within Life sciences or Pharmaceuticals (or related) desirable.
- First year University level or equivalent seeking 12 months work experience during studies also considered.
- Understanding of basic inspection techniques and problem solving skills needed. Experience working in FDA, GMP and ISO environments preferred.
- Proficient in Word and Excel, and good writing skill is needed. Experience in MS Access, MS Visio, Agile, and SAP desirable.
- Strong written and verbal communication essential.
- Highly motivated individuals with the ability to work from own initiative as well as part of a fast paced team.
- Availability to start immediately or within short notice desirable.
- Access to own transport essential due to location with limited public transport.
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.
As an organisation we specialise in four main areas:
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 over 16,000 employees around the world. Annual sales in 2017 of more than $4.8 billion.
We are a constituent of the UK's FTSE100 and our shares are traded on the London Stock Exchange and through American Depository Receipts on the New York Stock Exchange (LSE: SN, NYSE: SNN) .
If you share our passion for pioneering innovation and can demonstrate how you meet the criteria outlined, we would love to hear from you. When applying please provide details of current remuneration package along with salary expectations
We continue to actively build an environment where every individual can fulfil their potential and be proud ambassadors for Smith & Nephew, our customers and their patients. We value the diversity of our people and welcome applications from everyone.