Sr Quality Systems Specialist
Careers that Change Lives
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes. There are four divisions within RTG: Brain Therapies, Pain Therapies, Specialty Therapies and Spine.
In this exciting role as a Sr. Quality Systems Specialist, you will have responsibility for partnering with the organization in the execution of Nonconformance (NC) and CAPA activities to ensure the CAPA program is efficient, effective and compliant. You will apply knowledge and experience to ensure compliance to our NC and Corrective Action and Preventative Action (CAPA) processes and Medical Device regulations and requirements. In addition, work to improve the CAPA program including CAPA processes, enterprise software systems, reporting of metrics and trends and training programs.
Responsibilities may include the following and other duties may be assigned:
- As CAPA team member, support a wide portfolio of NCs and CAPAs to ensure process compliance, appropriate rigor and timely execution including, but not limited to:
- Evaluation of CAPA investigations, action execution, effectiveness determination, associated decisions and CAPA documentation.
- Support NC and CAPA teams in understanding the processes, best practices, record content, and software tools.
- Development of robust quality NC and CAPA files and records.
- Provide continuous improvement and rigorous assessment of CAPA activities and documentation to assure compliance with Neuromodulation CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements through the review of CAPA records at critical phases.
- Support and mentor NC and CAPA Owners in planning and executing the processes, best practices, record content, and software tools.
- Support the development and implementation of Quality System NC and CAPA procedures, software, and training programs.
- Support external and internal audits and inspections for NC and CAPA records and processes.
- Provide expert guidance in interpreting governmental regulations, agency guidelines and Medtronic internal policies in general and specific to CAPA to assure compliance.
- Understand all Neuro quality policy/system interfaces and dependencies to NC and CAPA processes and best practices.
- Complete other NC, CAPA and quality related functions and projects as assigned.
Must Have: Minimum Requirements
Bachelor's degree with 4+ years of work experience in Quality or regulated industry OR Advanced degree with 2+ years of work experience in Quality or regulated industry
- Knowledge of FDA regulations (21 CFR 820), ISO 13485
- Degree in Science or Engineering
- Experience in the medical device or pharmaceuticals industry
- Experience working with non-conformances, and corrective action and preventive action processes
- Experience with quality tools and process improvement techniques
- Strong critical thinking and analytical skills
- Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
- Lean Sigma certified or demonstrated problem solving experience
- Independent compliance decision maker (based on knowledge of regulations, available relevant information, alternatives, risk)
- Influence management skills; ability to work constructively across all functions of the organization and build relationships
- Strong technical writing and documentation review skills
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)
