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Senior NPI Quality Engineer-Medical Devices, IQ/OQ/PQ validation
3 months ago
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
iRhythm Technologies, Inc. is seeking a highly skilled and experienced Senior Quality Engineer to join our vibrant team during this pivotal phase of our growth journey. As a Senior New Product Introduction (NPI) Quality Engineer, you will hold a critical position within our New Product Introduction Quality Engineering group, providing indispensable support across both our development and manufacturing areas.
Your responsibilities include offering comprehensive quality engineering support to iRhythm's development and manufacturing teams, with a specialized emphasis on product and process design transfers. The role will encompass a broad spectrum of activities, including facilitating new product launches, overseeing site/process expansions, managing significant and minor product/process modifications, and driving strategic manufacturing-led initiatives including international expansions.
This position is based at our manufacturing facility located in Cypress, CA, and is a full-time opportunity. We are proud to offer an outstanding benefits package along with competitive compensation. Join us at iRhythm as we continue to innovate and make strides in the medical technology industry.
Responsibilities
- Actively participate as the Quality representative for projects within scope of this role.
- Partner with Design Quality Engineering to ensure successful product transfer into manufacturing
- Apply engineering principles and quality regulations to drive validation and qualification executions during transfer phases for new product introductions and ongoing design control projects for product changes (including reviewing and approving protocols)
- Actively participate in execution oversite for IQ/OQ/PQs, TMVs, engineering studies, and verifications
- Apply statistical knowledge to complete and analyze datasets, interpret results, and provide data driven feedback to design and manufacturing teams.
- Participate in development and continuous improvement of applicable procedures to ensure the compliance with applicable standards and industry practices
- Produce technical reports to support quality assurance investigations as needed
- Participates as NPI quality representative to associated risk documentation
Required Qualifications
- Bachelor’s Degree in an applied science or engineering field
- Minimum of 5 years of experience in Quality Assurance or Manufacturing of class II/III or equivalent experience
- At least 1 years of experience within Design Control
- Demonstrated competency with 21 CFR 820, ISO 13485, ISO 14971
- Strong organizational skills
- Experience in using Microsoft Excel, Word, and Visio
- Experience in root cause analysis
- Exceptional cross-functional communication skills and strong attention to detail
- Demonstrated ability to address technical challenges with creative problem-solving techniques.
- Ability to travel up to 10%
Preferred Qualifications
- The ideal candidate has electro-mechanical experience
- Six-Sigma Certification preferred
- Experience with Lean Manufacturing preferred
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
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
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.
