- Evaluates incoming complaint information and maintains the record in the electronic database.
- Performs follow up activities to obtain additional information. Use and maintain database(s), provide analysis and trending data all on complaints.
- Determines Reportability of complaints to Government Agencies.
- Identify and document appropriate complaint categories to assure trend accuracy within the complaint database.
- Writes investigation summaries based on technical product analysis information provided;
- Ensures record documentation is maintained in a constant state of audit readiness per internal policies.
- Liaison with groups who perform additional investigation and who prepare written record of investigation.
- Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing.
- Provide basic technical expertise and assistance in handling complaints to comply with current FDA and International reporting regulations.
- Reviews and interprets risk management documentation as it applies to the complaint event.
- Interacts with multiple departments within Medtronic - such as Technical Services, Failure Investigation, R & D, Manufacturing and Engineering.
- Interacts with groups external to Medtronic - such as customers, vendors, health care professional
- Initiate process improvements through Lean Sigma, DMAIC and automation
Required Knowledge and Experience
- Bachelor degree; Engineering or Science degrees preferred (eg SW,EE, ME, Biomedical Engineering)
- 9+ years quality assurance or regulatory experience in medical or pharmaceutical industry.
- Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysis
- Strong typing skills and ability to write business documents with minimal supervision.
- Strong verbal and written communication skills and ability to work in a team oriented environment
- Ability to be proactive and lead initiatives technically
- Ability to multitask.
- Ability to understand the functionality / intended use of complex medical devices.
- Minimum travel may be required
Nice to Haves
- Knowledge of medical devices, their development and quality control.
- Knowledge of FDA, MEDDEV, Canadian Regulations.
- Technical Writing experience.
