Top 68 Product complaint specialist Jobs in Irvine, Ca

Clinical Complaint Specialist
Masimo —Irvine, CA
- $80,000 - $100,000 a year
- Full-time
- Nursing
- Schematics
- RN License
- Paid parental leave
- AD&D insurance
Tech Support Specialist
Red Digital Cinema, Inc. —Foothill Ranch, CA
- $28 - $34 an hour
- Hybrid work
- Bilingual
- Bachelor of Science
- Mid-level
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On Site Property Manager Permanent Supportive Housing- 1 bedroom Unit
Trillium Property Management —Santa Ana, CA
- $25 - $27 an hour
- Part-time
- Spanish
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Dental insurance
Quick Apply
Merchant Service Customer Support Rep (Bilingual in Mandarin)
Menusifu, Inc. —Walnut, CA
- $45,000 - $50,000 a year
- Weekends as needed
- Hybrid work
- Customer service
- Writing skills
- Office
- Health insurance
- Dental insurance
Quick Apply
Operations Risk Support Specialist
Pacific Life Insurance Company —Newport Beach, CA
- $31.89 - $38.97 an hour
- Full-time
- Hybrid work
- Bachelor of Science
- Mid-level
- Office
- Paid parental leave
- Paid holidays
Quick Apply
Post Market Surveillance Specialist
RxSight, Inc. —Aliso Viejo, CA
- $85,000 - $95,000 a year
- Full-time
- Nursing
- Mid-level
- Mentoring
Quick Apply
Intake Coordinator
CareConnect Health Services Inc —Costa Mesa, CA
- Full-time
- Hybrid work
- Microsoft Outlook
- Mid-level
- High school diploma or GED
- COVID-19 protective measures
Quick Apply
Program Admin Specialist (SSO Division – Location: Irvine, CA)
Parker Hannifin Corporation —Irvine, CA
- $100,300 - $159,400 a year
- Full-time
- Bachelor of Science
- Mid-level
- Office
- Paid parental leave
- Paid holidays
Senior End User Support Specialist
SCAN Group —Long Beach, CA
- $34.47 - $47.50 an hour
- Full-time
- Remote
- Background check
- 5 years
- Research
- Wellness program
- Paid holidays
Quick Apply
12d
Service Support Specialist
Harbinger Motors Inc. —Garden Grove, CA
- $80,000 - $110,000 a year
- Email
- Bilingual
- Mid-level
- Travel
Quick Apply
3d
Contract Specialist
Parker Hannifin Corporation —Irvine, CA
- $100,300 - $159,400 a year
- 5 years
- Mid-level
- Office
- Paid parental leave
- Paid holidays
Regulatory Affairs and Quality Assurance Specialist
SprintRay —Huntington Beach, CA
- $90,000 - $120,000 a year
- Full-time
- 5 years
- Research
- Mid-level
Tech/Customer Support Specialist
Xppen Technology Co —Chino Hills, CA
- $3,300 a month
- Full-time
- High school diploma or GED
- Computer skills
- Communication skills
- Health insurance
- 401(k)
Quick Apply
3d
Sales Support Specialist - CA
PEI-Genesis —Santa Ana, CA
- $50,000 - $60,000 a year
- Full-time
- Hybrid work
- Microsoft Outlook
- ERP systems
- Mid-level
Quality Assurance Analyst
University of California, Irvine —Irvine, CA
- $97,000 - $182,200 a year
- Full-time
- Background check
- Nursing
- Customer service
- Health insurance
- Retirement plan
Food Safety and Quality Assurance Specialist
ASIA INTERNATIONAL, INC. —Santa Ana, CA
- $64,000 - $65,000 a year
- Mid-level
- Communication skills
Quick Apply
Employee Relations Specialist
Kura Sushi Corporate Support Center —Irvine, CA
- $30 - $33 an hour
- Weekends as needed
- Hybrid work
- Spanish
- English
- Mid-level
Quick Apply
Purchasing Specialist - Military Flight Controls Division
Parker Hannifin Corporation —Irvine, CA
- $87,050 - $145,250 a year
- Full-time
- Research
- Mid-level
- Bachelor's degree
- Paid parental leave
- Paid holidays
9d
Resident Support Services Specialist
FirstService Residential —Irvine, CA
- $22 - $25 an hour
- Extended hours
- Background check
- Microsoft Excel
- Microsoft Outlook
- Health savings account
- Paid holidays
Quick Apply
Relationship Banking Specialist I
California Bank of Commerce, N.A. —Irvine, CA
- $28 - $33 an hour
- Full-time
- Office
- High school diploma or GED
- Analysis skills
11d

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Clinical Complaint Specialist

Masimo -
Irvine, CA

Apply Now

Job Details

Full-time
$80,000 - $100,000 a year

Benefits

Paid parental leave
AD&D insurance
Paid holidays
Disability insurance
Health insurance
On-site gym
Dental insurance
401(k)
Flexible spending account
Parental leave
Employee assistance program
Vision insurance
Pet insurance

Qualifications

Computer operation
Direct patient care
Schematics
Interpreting technical drawings
English
Desktop applications
Document review
Productivity software

Full Job Description

Job Summary

The Clinical Complaint Specialist is responsible for the clinical assessment, evaluation, and processing of medical device complaints in support of regulatory compliance and product safety activities. This role applies clinical expertise to evaluate complaint events, assess potential patient impact, determine regulatory reportability, support investigations, and ensure accurate complaint documentation. The Clinical Complaint Specialist partners cross-functionally to support complaint handling, post-market surveillance, and continuous improvement initiatives.

Duties & Responsibilities

Review, evaluate, and process medical device complaints in accordance with applicable regulations, company procedures, and quality system requirements.
Perform clinical assessments of complaint events to determine severity, potential patient impact, and device-relatedness.
Evaluate complaints for regulatory reportability, including Medical Device Reporting (MDR), vigilance reporting, and other applicable global adverse event reporting requirements.
Classify and code complaint events using established coding systems and internal procedures.
Review complaint records for completeness and obtain additional information as necessary to support complaint evaluations and investigations.
Document complaint assessments, reportability determinations, and supporting rationale within complaint management systems.
Support the preparation, review, and submission of adverse event reports to regulatory authorities as required.
Collaborate with Quality, Regulatory Affairs, Medical Affairs, Clinical Affairs, Engineering, Manufacturing, and other cross-functional teams to support complaint investigations and resolution activities.
Identify and escalate potential product safety concerns, emerging risks, and quality issues.
Participate in post-market surveillance activities, including complaint trending, signal detection, and risk assessments.
Support internal audits, regulatory inspections, and quality system assessments related to complaint handling processes.
Assist with the development, maintenance, and continuous improvement of complaint handling procedures, work instructions, and quality system documentation.
Maintain current knowledge of applicable regulations, standards, and industry best practices related to complaint handling and post-market surveillance.

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications

Registered Nurse (RN), Bachelor of Science in Nursing (BSN), or equivalent clinical degree.
Minimum three (3) years of clinical nursing or direct patient care experience.
Strong clinical assessment and critical thinking skills.
Ability to interpret medical records, clinical documentation, and adverse event information.
Strong written, verbal, and interpersonal communication skills.
Strong attention to detail and organizational skills.
Proficiency with Microsoft Office applications.

Preferred Qualifications

Experience in the medical device, biotechnology, pharmaceutical, diagnostics, or healthcare industry.
Experience with complaint handling, adverse event reporting, post-market surveillance, or quality systems.
Knowledge of FDA Medical Device Reporting requirements (21 CFR Part 803), complaint handling requirements (21 CFR Part 820), and applicable international vigilance regulations.
Experience using electronic quality management systems (eQMS) or complaint management systems.
Advanced clinical degree or specialty certification.

Education

Registered Nurse (RN), Bachelor of Science in Nursing (BSN), or equivalent clinical degree required.
Advanced clinical degree or specialty certification preferred.

Compensation:

The anticipated salary range for this position is $80,000 - $100,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.

This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.

Masimo offers benefits such as Medical, Dental, Vision, Life/AD&D, Disability Insurance, 401(k), Vacation, Sick, Holiday, Paid Maternity Leave, Flexible Spending Accounts, Voluntary Accident, Critical Illness, Hospital, Long-Term Care, Employee Assistance Program, Pet Insurance, On-site wellness clinic, fitness center, and cafe. All benefits are subject to eligibility requirements.

Language requirements

Ability to read, write, and communicate effectively in English.
Ability to interpret technical documents, schematics, and written instructions.
Ability to clearly document technical findings and communicate with cross-functional team members.

Physical requirements/Work environment

This position primarily works in an office environment and requires frequent sitting, standing, and walking. Daily use of a computer and other digital devices is required. This role may require standing for extended periods when facilitating meetings or walking through facilities.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Masimo is proud to be an EEOE/, M/F/D/V, and we are committed to Diversity at the corporate level.

Apply Now

Refine Your Search

product complaint specialist jobs in irvine, ca

Clinical Complaint Specialist

Tech Support Specialist

On Site Property Manager Permanent Supportive Housing- 1 bedroom Unit

Merchant Service Customer Support Rep (Bilingual in Mandarin)

Operations Risk Support Specialist

Post Market Surveillance Specialist

Intake Coordinator

Program Admin Specialist (SSO Division – Location: Irvine, CA)

Senior End User Support Specialist

Service Support Specialist

Contract Specialist

Regulatory Affairs and Quality Assurance Specialist

Tech/Customer Support Specialist

Sales Support Specialist - CA

Quality Assurance Analyst

Food Safety and Quality Assurance Specialist

Employee Relations Specialist

Purchasing Specialist - Military Flight Controls Division

Resident Support Services Specialist

Relationship Banking Specialist I

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