QA Complaints Engineer I
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- Provides administrative expertise in receipt, processing, monitoring and reporting of product defect complaints, serving as primary contact.
- Addresses and expedites product complaints under the company's complaint policy and procedures, and ensures compliance with government regulations.
- Monitors complaint activity and provides suggestions to appropriate company authorities to modify existing manufacturing or packaging process based upon pattern and related analyses.
- Maintains unified product defect investigation operating procedures.
- Provides technical expertise to optimize complaint processing systems.
- Maintains and monitors systems to ensure that all product complaint investigations received are appropriately investigated and concluded per the company's complaint handling procedure.
- Bachelors degree required
- 0 years of experience required
Nice to Have
- Bachelors Degree in Industrial Engineering or equivalent.
- Minimum 2 years of experience in the medical devices.
- Advanced English level.
- Knowledge in Root Cause Analysis.
- Knowledge of Corrective and Preventive Actions.
- Knowledge in Failure Investigation.
- Knowledge of CFR 820 / ISO 13485.
- Knowledge in Validations.
- Knowledge of Minitab and advanced statistics techniques.
- Knowledge of Microsoft Office (Excel, Power point, Word)
Conduct and analyze customer defect trends, working with multidisciplinary teams to eliminate/reduce defects.
About Medtronic
Together, 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’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The 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)