Sr eQMS Quality Specialist

El Camino Health; United States; Remote; USD 96,000 - 125,000; Full time

Job summary

iRhythm Technologies, Inc. recherche un Sr. eQMS Quality Specialist pour améliorer la conformité et l'efficacité de son système de gestion de la qualité. Ce rôle est essentiel dans le cadre de l'amélioration de la qualité des produits et de l'expérience des patients, nécessitant une collaboration intensive et des compétences analytiques pointues.

Benefits

Assurance médicale

Contributions de l'employeur au compte d'épargne santé

Plan de congés payés

Assistance juridique

Stock options

Formation LinkedIn Learning illimitée

Qualifications

• Minimum de 5 ans d'expérience dans un rôle lié à la qualité ou à la réglementation.
• Minimum de 3 ans d'expérience en gestion des changements ou validation des logiciels.
• Doit établir des partenariats solides à travers les équipes fonctionnelles.

Responsibilities

• Collaborer avec les partenaires logiciels eQMS pour mettre en œuvre des mises à jour.
• Identifier proactivement les améliorations du système et des processus.
• Effectuer d'autres tâches liées à la qualité et à la réglementation.

Skills

Communication

Analyse

Collaboration

Résolution de problèmes

Détail

Job description

Career-defining. Life-changing.

At iRhythm, you'll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what's possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career

About This Role:

In this role the Sr. eQMS Quality Specialist will be responsible for Quality System compliance and identifying and implementing Quality System process improvements include, but are not limited to, system administration, process improvements in collaboration with process owners, and are a key contributor for eQMS system upgrades. You will ensure a fully compliant and efficient eQMS. This position is critical to improving product quality and patient experience.

Responsibilities:

• Collaborate with eQMS Software partners, as well as iRhythm's internal team, in order to implement upgrades and be accountable for the proper operation of the iRhythm eQMS system.

• Team member for projects related to the implementation of additional eQMS modules at iRhythm.

• Collaborate with cross-functional process owners and stakeholders, including eQMS Software partners to configure various process modules to enhance compliance and efficiency in order to meet iRhythm's growing needs.

• Proactively identify system and process improvements to ensure it is completed effectively and efficiently. Including system integration testing, validate product configurations for accuracy and alignment with customer requirements and end to end testing.

• Perform other quality and regulatory-related duties as assigned

• Provides support to the eQMS Software Partners to conduct end-to-end testing, including system integration testing, validate product configurations for accuracy and alignment with customer requirements.

Required Qualifications:

• Minimum of 5 years of experience in Quality or Regulatory related role

• Minimum of 3 years of experience in Change Control or relevant experience in Software Validation

• Build strong partnerships across functional teams within the organization

• Attention to detail and timeliness are critical

• Excellent communication (verbal and written) and interpersonal skills required

• Must operate through collaboration and transparency

• Must be a positive and energetic team member who is motivated to support iRhythm's Quality System

• Strong analytical, problem solving, and presentation skills, and strong attention to detail

• Ability to work as part of a diverse team

• Conduct audits to identify areas for improvement and compliance with regulations and industry standards.

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 LinkedIn Learning classes and so much more!

FLSA Status: Exempt

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 [e-mail]

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.

Location:

Remote - US

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range

$96,000.00 - $125,000.00

As a part of our core values, we ensure an 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 [e-mail]

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.