Sr Quality Systems Specialist (CAPA)
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor’s degree required
Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Nice to Have
Experience in medical device, pharmaceutical and/or a comparable regulated environment.
Experience reviewing technical documentation.
Experience working with non-conformances, corrective and preventive action reports.
Understanding of the following:
FDA 21CFR parts 820 and 11
ISO 13485
ISO 14971
Medical Device Directive
Canadian Medical Device Regulation
Japanese PAL regulation
Other applicable Harmonization Standards that apply to medical devices and instrumentation.
Experience in external inspections by regulatory bodies.
Experience in a matrix organization.
Influence management skills; ability to work constructively across all functions of the organization as well as external customers.
Strong written and verbal communication skills.
Strong analytical and decision-making skills.
Project and time management skills.
Experience with quality tools and process improvement techniques.
Knowledge of effective root cause investigation, corrective and preventive action planning, execution, and verification of effectiveness techniques.
Technical project management or quality engineering experience
Ability to educate people in Quality Systems and exercise good judgement
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)
Travel may be required (less than 10%)
