Quality Systems Specialist
Must haves: Minimum requirements:
A Bachelor’s Degree and 2 years of relevant experience.
Nice to haves:
Two years’ experience in Medical Device Industry inclusive of: Quality Systems, Document Control, and /or Training Administration.
Good communication skills, both written and oral in English and must be computer literate.
Experience in a regulated Medical Device work environment
Skills/Qualifications:
Experience with Agile Product Lifecycle Management (PLM) System
Experience with Cornerstone Learning Management Systems (LMS)
Experience working with Surgical Robotics systems
Knowledge of or experience in developing and manufacturing medical devices in conformance with Quality System Regulations including but not limited to ISO 13485 and FDA 21 CFR Part 820 requirements.
Knowledge of analytical tools and methods related to design, development and manufacturing.
Experience in a development & manufacturing environment, including:
Processing documentation, change orders, and workflows
Maintaining Design History File (DHF) & Device Master Record (DMR)
Skills/Qualifications: Proficient in Microsoft Office tools, including: Word, Excel, & PowerPoint
Working Conditions:
- Office environment where the employee would be standing and sitting most of the day at a desk or in a conference room for meetings.
- Candidate may be asked to travel periodically (<10% annually) to support the project(s) (~once or twice a year).
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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life 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.
EEO
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees .
