Job Description

Careers that Change LivesReview, evaluate, classify and perform follow up activities on all product complaints relative to the identity, quality, reliability, safety and effectiveness of medical devices. Evaluates for reporting criteria to Government Agencies to determine if the event reasonably suggests a device may have or could have caused or contributed to a death or serious injury.
A Day in the LifeIntake of source documents, promote them to complaints, follow-up with Reps, determine Reportability, file Regulatory Reports and write Investigation Summaries based on technical product analysis information provided by the plant.Must Have:Job Responsibilities\xc2\xb7 2+ year break in their career\xc2\xb7 8+ year professional engineering work experience\xc2\xb7 Evaluates incoming complaint information and maintains the record in the electronic database.\xc2\xb7 Performs follow up activities to obtain additional information. Use and maintain database(s), provide analysis and trending data all on complaints.\xc2\xb7 Determines Reportability of complaints to Government Agencies.\xc2\xb7 Identify and document appropriate complaint categories to assure trend accuracy within the complaint database.\xc2\xb7 Writes investigation summaries based on technical product analysis information provided;\xc2\xb7 Ensures record documentation is maintained in a constant state of audit readiness per internal policies.\xc2\xb7 Liaison with groups who perform additional investigation and who prepare written record of investigation.\xc2\xb7 Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing.\xc2\xb7 Provide basic technical expertise and assistance in handling complaints to comply with current FDA and International reporting regulations.\xc2\xb7 Reviews and interprets risk management documentation as it applies to the complaint event.\xc2\xb7 Interacts with multiple departments within Medtronic - such as Technical Services, Failure Investigation, R & D, Manufacturing and Engineering.\xc2\xb7 Interacts with groups external to Medtronic - such as customers, vendors, health care professional\xc2\xb7 Initiate process improvements through Lean Sigma, DMAIC and automation.Minimum Qualifications\xc2\xb7 Bachelor degree; Engineering or Science degrees preferred (e.g. SW,EE, ME, Biomedical Engineering)\xc2\xb7 9+ years quality assurance or regulatory experience in medical or pharmaceutical industry.\xc2\xb7 Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysis\xc2\xb7 Strong typing skills and ability to write business documents with minimal supervision.\xc2\xb7 Strong verbal and written communication skills and ability to work in a team oriented environment\xc2\xb7 Ability to be proactive and lead initiatives technically\xc2\xb7 Ability to multitask.\xc2\xb7 Ability to understand the functionality / intended use of complex medical devices.\xc2\xb7 Minimum travel may be required .
Nice to Have\xc2\xb7 Knowledge of medical devices, their development and quality control.\xc2\xb7 Knowledge of FDA, MEDDEV, Canadian Regulations.\xc2\xb7 Technical Writing experience.
About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let\xe2\x80\x99s work together to address universal healthcare needs and improve patients\xe2\x80\x99 lives. Help us shape the future.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)Additional Information

• Posting Date: May 24, 2024
• Travel: No

Medtronic