Senior eQMS Quality Specialist

Employment Type: Full-time

Position Overview

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.

In this role, the Sr. eQMS Quality Specialist will be responsible for Quality System compliance and identifying and implementing Quality System process improvements. This includes, but is not limited to, system administration, process improvements in collaboration with process owners, and being 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.
• Perform system integration testing, validate product configurations for accuracy and alignment with customer requirements, and conduct 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, and validate product configurations for accuracy and alignment with customer requirements.
• Conduct audits to identify areas for improvement and compliance with regulations and industry standards.

Requirements

• Minimum of 5 years of experience in a 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.

What’s in it for you

This is a regular full-time position with a 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 a 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!

Company Information

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. As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and encourage applications from all qualified individuals.

FLSA Status: Exempt