- 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 on all complaints.
- Determines Reportability of complaints and submits Regulatory Reports 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 - RTG, such as Technical Services, Failure Investigation, R & D, Manufacturing and Engineering.
- Interacts with groups external to Medtronic - RTG, such as customers, vendors, health care professional
Minimum Qualifications
- Bachelor degree; Engineering or Science degrees preferred (e.g. ECE, Biomedical Engineering, ME)
- 4-8 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 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 medical device standards.
- Knowledge of FDA, MEDDEV, Canadian Regulations.
- Technical Writing experience.
Employment Type: Full Time, Permanent
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