Details
Posted: 26-May-22
Location: Houston, Texas
Type: Full Time
Preferred Education: 4 Year Degree
Salary: $75,000 - $85,000
Categories:
Quality
Quality Engineering
Internal Number: REQ# 00050YR2022
We are
Medical Informatics Corp. (MIC) a medical software company that aims to save lives by improving how patients are monitored. Our solution, Sickbay, collects patient data, stores it, transforms it and delivers results to doctors and nurses in real-time. We continue to build on Sickbay to identify early warning signs of patient deterioration in data which was previously lost within hospitals. This allows us to provide predictive alerts to care providers who can remotely or locally diagnose the problem and intervene before symptoms become life-threatening.
You are
Are you a technology enthusiast who would like to work with a group of diverse, smart, innovative problem solvers in a rewarding, fast paced growth environment?
Are you an active learner interested in challenging the status quo to disrupt the current model of remote patient monitoring and predictive analytics in healthcare?
Would you like to work with a unique, state of the art FDA cleared platform that improves patient outcomes and ultimately saves patient lives?
Are you looking for a new opportunity with a clear path for advancement based on your success?
At Medical Informatics Corp, we are committed to:
- Curiosity and the freedom to explore
- A spirit of collaboration and understanding
- Making sure the work you do is meaningful, fun and well balanced with the rest of life’s priorities
Motivated by problems that matter. You love to learn and are constantly looking for the most elegant way to solve problems that push the limits of what you know. You have solid work ethics and commitment to the team. You ask and answer questions with enthusiasm.
Duties and Responsibilities
- Ensure the Medical Informatics Corp. Quality System policies and corresponding processes are followed properly by conducting internal audits according to the company’s Annual Audit Plan.
- Prepare comprehensive audit documentation related to process validation and findings.
- Effectuate cross-department communication to ensure audit findings are timely addressed and rectified to maintain compliance with regulation requirements.
- Manage corrective and preventive actions (CAPA), perform investigations, root cause investigations, corrective action plan and implementation, and effectiveness verification plan and implementation.
- Collect and report Quality metrics and data, as requested.
- Investigation, evaluation and reporting of adverse events incidents or device malfunctions as required by FDA and international regulatory authorities.
- Assist in the testing and validation of company products.
- Evaluate quality events, incidents, queries, and complaints.
- Coordinate and execute quarterly tabletop exercises for MIC’s incident response plan and disaster recovery/business continuity plan.
- Develop content for company-wide quality system training and work with the Training Coordinator to ensure effective implementation of the same.
- Performs other tasks related duties as assigned by CCO
Required Qualifications - A Bachelor’s degree in a relevant field of study; degrees in Technical Communications, English, or Writing are preferred.
- Experience serving as a Quality System Internal Auditor or Quality Assurance Manager in a healthcare technology environment.
- Certified Auditor by the American Society for Quality for Auditing Fundamentals levels 1 and 2. (If not currently certified, this is a requirement within 90 days of the hiring date.)
- Comfortable with learning and using new technologies
- Strong time management skills and organizational skills, with a high attention to detail.
- Excellent analytical/problem-solving skills
- Strong verbal/written communication skills across different employees and departments
- Ability to self-initiate and work independently on projects
- Ability to edit and proofread work of colleagues
Preferred Qualifications - 1-3 years of related compliance department/ quality system management experience
- Experience with the following applications: Github, Smartsheet, & Confluence
- Healthcare quality experience
- Understanding of computer software development
Your mission The Quality Assurance Manager supports all functions of the compliance department in maintaining a compliant quality system for Medical Informatics Corp. The Quality Assurance Manager serves as a primary team member responsible for advising the Chief Compliance Officer on quality and regulatory policy and communicating updates of the Quality System across Departments. Your reward - Market value-based salary for a Quality Assurance Manager ($75K to $85K)
- Health Benefits (med/den/vis/company paid STD/LTD & Life Ins./HSA's/FSA’s)
- Paid Time Off (PTO)
- 11 Paid Holidays
- 401k Investment Opportunity
- Flexible work schedule
- Knowing that the work you do makes a difference in the lives of patients and the clinicians that take care of them
- Working with a great team with different backgrounds
- Increase personal knowledge base
"This position requires in-person meetings at the Houston office or at client sites. COVID-19 vaccination is mandatory, unless otherwise accommodated, in accordance with company policy." Required submissions Please submit all of the following. Incomplete applications will not be considered! - Resume
- Cover letter (Why do you want to work for MIC? What makes you a great candidate?)
Kindly provide us with: - Three references with contact information (We will not contact them until later in the hiring process)
- A joke (Something that makes you laugh!)
- Create a new portmanteau, define that portmanteau, and use it in a sentence. (Tell us the two words you used to create one!)
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