- Quality Specialist - Post Market Complaints
- Go to our website »
Quality Specialist - Post Market Complaints
Boldly innovating to create trusted solutions that detect, predict, and prevent disease.
Discover your power to innovate while making a difference in patients' lives. iRhythm is advancing cardiac care…Join Us Now!
At iRhythm, we are dedicated, self-motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and committed to iRhythm's employees and the mission of the company. We are better together, embrace change and help one another. We are Thinking Bigger and Moving Faster.
About this role:
The QA Specialist - Post Market will support the growth and continuous improvement of the Complaint Quality System, providing hands-on support to ensure complaints are reviewed and assessed in a timely manner. Duties include, but are not limited to, day to day complaint review, investigation reports, adverse event reporting and complaints log and trend maintenance.
Responsibilities:
- Evaluates complaints to determine complaint investigation, Medical Device and Vigilance Reporting in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting.
- Performs and/or coordinates complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports
- Evaluate all information from a technical perspective to ensure appropriate Analysis and Investigation
- Reviews daily processes to ensure issues are being addressed and escalated in a timely manner
- Maintains complaints log
- Participates in process improvements
- Perform other quality and regulatory-related duties as assigned
Required Qualifications:
- Bachelor's Degree
- Minimum of 2 years of experience in Quality Assurance with complaint processing role.
- Previous experience in medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR
- Strong problem-solving skills, critical-thinker, and experienced at investigating and resolving complex issues
- Understand basic principles of good technical writing skills
- Must work across functional teams within the organization
- Attention to detail and timeliness are critical
- Excellent communication (verbal and written) and interpersonal skills required
- Demonstrated experience with MS Word, Excel, Adobe Acrobat, and other commonly used software systems
- Basic statistical methods including trend analysis
- Basic knowledge of Quality Systems (CAPA/non-conformances/SCARS) a plus
- Must be able to work under minimum supervision and in a team environment.
- Must be a positive and energetic team player
- Must be able to work from home or hybrid (remote/at site)
- Experience with software/firmware related complaints a plus.
What's in it for you:
This is a regular full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurances (all of which start on your first day), health savings account employer contributions (when enrolled in high deductible medical plan), cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts), travel reimbursement for medical care, noncontributory basic life insurance & short/ long term disability.
Additionally, we offer:
- Emotional health support for you and your loved ones
- Legal / financial / identity theft/ pet and child referral assistance
- Paid parental leave, paid holidays, travel assistance for personal trips and PTO!
- Wellness/ cultural committee/charity events
iRhythm also provides additional benefits including 401(k) (with company match), an Employee Stock Purchase Plan, pet insurance discount, unlimited amount of Linked In Learning classes, and so much more!
FLSA Status: Exempt
#LI-JR1
Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.
iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at taops@irhythmtech.com
About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm's vision is to deliver better data, better insights, and better health for all.
Make iRhythm your path forward. Zio, the heart monitor that changed the game.
jeid-712e064b682fce409be0d0b70417730d
