Job Details

JOB DESCRIPTION
Spotlight Call with HM:
8/7 @ 2pm CST
Dial in by phone
+***,
Phone conference ID: 531 087 416#

Target BR: ***/hr

HM's Top Needs:
1. Design Control
2. Experience in ISO 13485
3. Class III medical device experience

Education Required: Bachelors degree
Years' Experience Required: Bachelors degree with 4+ years of work experience or 2 years with advanced degree.
Will the contractor be working 40 hours a week? If not, weekly estimate? 40hrs a week
Work Location: Remote
Do they need to be local to any MDT office and if so where?
Does this person need to be on site? If so, full time or part time?

Senior Quality Systems Specialist
Careers That Change Lives
In this exciting role as a Sr. Quality Systems Specialist you will have responsibility for compliance to Quality System processes and Medical Device regulations and requirements.
Structural Heart and Aortic
The Structural Heart and Aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves-aortic, pulmonic, mitral, tricuspid-and the placement of stent grafts to treat aneurysms and dissections of the body's largest artery, the aorta
Day in the Life
Responsibilities may include the following and other duties may be assigned.
Provide continuous and rigorous assessment of quality system to assure compliance with our client internal policies in general and specific to quality system processes, FDA part 820.30 regulations (Design Controls, specifically Design Changes), ISO 13485, Medical Device Requirements, and governmental regulations.
Participates in Quality System process activity across multiple sites including quality system projects and initiatives.
Participate in, and own CAPA management activities, including corrective actions and effectivity strategies.
Conduct root cause investigations of Quality System compliance issues; complete data analysis on investigation findings.
Support the development and implementation of Quality System procedures.
Performs other related duties as assigned.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor's degree with 4+ years of work experience in Quality, Manufacturing, or regulated industry OR Advanced degree with 2 years of work experience in Quality or regulated industry
Desired Skills
Experience in a regulated environment
Experience working with audit findings, corrections, and corrective actions
Experience in medical device, pharmaceutical and/or a comparable regulated environment
Influence management skills; ability to work constructively across all functions of the organization as well as external customers
Project management skills
Quality System documentation systems (e.g. Agile) and Audit documentation systems experience (e.g. Trackwise)
Experience reviewing technical documentation
Strong written and verbal communication skills
bility to educate people in Quality Systems and the Audit program
Experience with quality tools and process improvement techniques
Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
Strong analytical and decision-making skills
Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and our client quality requirements in general and specific to CAPA.
bout our client
Together, we can change healthcare worldwide. At our client, 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 10% domestic and internationally