Senior QA Clinical Specialist- Post Market

El Camino Health; United States; Remote; USD 91,000 - 118,000; Full time

Job summary

A leading healthcare company is seeking a Senior QA Clinical Specialist to manage complaint handling and ensure compliance with regulatory standards. This fully remote position offers a competitive salary and benefits, focusing on improving patient care and cardiac health solutions. Join a dedicated team committed to innovation and quality.

Benefits

Medical, dental, and vision insurances

401(k) with company match

Paid parental leave

Unlimited LinkedIn Learning classes

Qualifications

• Minimum 5 years of experience in medical terminology, nursing, clinical or laboratory knowledge.
• Minimum 5 years of experience in complaint handling, medical device industry, customer relations.
• In-depth knowledge of Quality System standards and regulations.

Responsibilities

• Manage the end-to-end process of the complaint handling system.
• Review and verify the accuracy of complaint information.
• Assist in drafting and submitting Medical Device Reports (MDRs).

Skills

Analytical skills

Communication skills

Interpersonal skills

Problem-solving skills

Education

BA or BS degree in Science, Health Administration, Nursing, or related field

Tools

Quality System standards

Job description

Senior QA Clinical Specialist- Post Market page is loaded

Senior QA Clinical Specialist- Post Market

Apply remote type Fully Remote locations Remote - US time type Full time posted on Posted 3 Days Ago job requisition id JR20

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:

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:

Specific responsibilities include but not limited to:

• Manage the end-to-end process of the complaint handling system
• Review and verify the accuracy of complaint information
• Triage complaints and determine required information needed to assess reportability decisions and conduct thorough product investigations.
• Follow established procedures to ensure timely and accurate execution and review of decision trees.
• Assist in drafting and submitting Medical Device Reports (MDRs), eMDR, and PDMA reports.
• Monitor and facilitate the timely reporting of MDRs and supplemental MDRs.
• Ensure compliance with iRhythm’s policies, procedures, and regulatory requirements.
• Route complaints to appropriate departments for further evaluation as needed.
• Interface and communicate with customers via phone, chat, and email when required.
• Provide training to personnel involved in the complaint handling process as directed by management.
• Identify missing critical information for follow up with customers and vendors for additional information or clarification.
• Engage with healthcare workers, consumers, and professionals regarding their quality concerns.
• Stay current on product knowledge and any updates to the complaint handling system.
• Maintain expert-level knowledge of the complaint handling system.
• Perform other duties as assigned.

About You:

Experience:

• BA or BS degree in Science, Health Administration, Nursing, or related field (or equivalent combination of education and experience). RN license required.
• Minimum 5 years of experience in medical terminology, nursing, clinical or laboratory knowledge.
• Minimum 5 years of experience in complaint handling, the medical device industry, customer relations, complaint trending, and FDA/ISO regulations.

Knowledge and Skills:

• In-depth knowledge of Quality System standards and regulations, including 21 CFR 803 & 820, ISO 13485, and Canadian regulations.
• Strong understanding of product usage, including the ability to assess health risks to patients or healthcare workers.
• Experience working with customer system administrators and clinicians.
• Expert-level knowledge of complaint handling systems.
• Ability to work independently with minimal supervision, demonstrating ownership of tasks.
• Strong analytical, deductive reasoning, and listening skills.
• Excellent written and verbal communication skills with the ability to communicate precisely and accurately at all organizational levels.
• Strong interpersonal skills with the ability to build relationships.
• Ability to think creatively and provide innovative solutions to complex customer issues.
• Excellent time management and multitasking skills.
• Commitment to quality, customer service, and patient safety.

Additional Qualifications:

• Candidates should have a nursing background, ideally in cardiac or dermatology, to review complaints for reportability to the FDA.
• The ability to write medical justifications for reportability determinations is a key requirement.
• This position requires a unique blend of clinical expertise, regulatory knowledge, and complaint handling skills to ensure accurate and compliant reporting of complaints to the FDA.

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

$91,000.00 - $118,000.00

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.