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Complaint Management Medical Device Jobs (NOW HIRING)

Senior Complaint Specialist

Austin, TX · Hybrid

$75K - $100K/yr

... manage timely complaint review and closure. * Regulatory Reporting: Ensure timely and accurate Medical Device Reporting (MDR) and adverse event reporting to external regulatory authorities as ...

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company ... Perform other duties as assigned by Quality Management. Who You Will Report To: * Sr. Manager ...

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Complaint Management Medical Device information

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$39K

$68.7K

$97.5K

How much do complaint management medical device jobs pay per year?

As of Aug 1, 2026, the average yearly pay for complaint management medical device in the United States is $68,656.00, according to ZipRecruiter salary data. Most workers in this role earn between $66,000.00 and $69,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in Complaint Management for Medical Devices, and why are they important?

To thrive in Complaint Management for Medical Devices, you need a solid understanding of regulatory requirements (such as FDA and ISO standards), quality management systems, and product knowledge, often supported by a degree in life sciences or engineering. Familiarity with complaint handling software, CAPA systems, and documentation tools is typically required, along with experience in root cause analysis. Strong attention to detail, effective communication, and problem-solving abilities are crucial soft skills for investigating and resolving complaints. These skills ensure compliance, patient safety, and continuous product improvement in a highly regulated industry.

What are some common challenges faced in a Complaint Management role within the medical device industry?

Professionals in Complaint Management for medical devices often face challenges such as ensuring compliance with complex regulatory requirements, maintaining accurate documentation, and coordinating timely responses to customer complaints. The role requires effective communication with cross-functional teams—including quality assurance, regulatory affairs, and engineering—to investigate and resolve issues. Balancing thorough investigations with prompt reporting is crucial to meeting both patient safety and regulatory obligations. Additionally, staying updated on evolving regulations and industry standards is essential for ongoing success in this position.

What is the difference between Complaint Management Medical Device vs Quality Assurance Medical Device?

AspectComplaint Management Medical DeviceQuality Assurance Medical Device
CertificationsISO 13485, Medical Device RegulationsISO 13485, Medical Device Regulations
Work EnvironmentCustomer complaints, post-market surveillanceProduct testing, process audits
Employer & Industry UsageMedical device companies, post-market teamsManufacturers, quality departments

Complaint Management Medical Device professionals focus on handling and investigating customer complaints related to medical devices, ensuring compliance and product safety. In contrast, Quality Assurance Medical Device staff oversee overall product quality, conduct audits, and implement process improvements. While both roles require similar certifications and work within the medical device industry, Complaint Management specialists concentrate on post-market issues, whereas Quality Assurance professionals focus on preventing defects during manufacturing.

What is complaint management in the medical device industry?

Complaint management in the medical device industry refers to the process of receiving, documenting, investigating, and resolving complaints related to medical devices. This process ensures that any issues or adverse events reported by users, healthcare professionals, or patients are handled in compliance with regulatory requirements. Effective complaint management helps manufacturers identify potential product problems, improve device safety, and maintain regulatory compliance. It also involves reporting certain complaints to regulatory authorities when required, such as the FDA or European Medicines Agency.
More about Complaint Management Medical Device jobs
What cities are hiring for Complaint Management Medical Device jobs? Cities with the most Complaint Management Medical Device job openings:
What states have the most Complaint Management Medical Device jobs? States with the most job openings for Complaint Management Medical Device jobs include:
Infographic showing various Complaint Management Medical Device job openings in the United States as of July 2026, with employment types broken down into 83% Full Time, 13% Part Time, 1% Temporary, 1% Contract, 1% Nights, and 1% Summer. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $68,656 per year, or $33 per hour.

Medical Device Complaint Trending Expert (Any Facility)

Integra LifeSciences

Princeton, NJ • On-site

$81K - $112K/yr

Full-time

Medical, Dental, Vision, Life, Retirement

Re-posted 23 days ago


Integra LifeSciences rating

9.4

Company rating: 9.4 out of 10

Based on 9 frontline employees who took The Breakroom Quiz


Job description

Changing lives. Building Careers.
Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
The Medical Device Complaint Trending Expert is responsible for the end-to-end development, execution, and oversight of complaint data trending and signal detection activities to ensure timely identification of product quality, safety, and compliance risks. This role serves as a subject matter expert (SME) for complaint analytics, statistical trending methodologies, and regulatory expectations related to post-market surveillance.
The individual partners cross functionally with Quality, Regulatory Affairs, Risk Management, R&D, Manufacturing, and Medical Safety to translate complex complaint data into actionable insights that support corrective and preventive actions (CAPA), regulatory submissions, and risk management decisions.
ESSENTIAL DUTIES AND RESPONSIBILITIES
  • Work end to end complaint trending data and analysis
  • Identify trends within complaints being able to know the difference between variation vs signal.
  • Design, maintain, and continuously improve complaint trending methodologies aligned with regulatory and business risk principles
  • Perform routine and ad hoc trending analyses to identify statistically significant signals, emerging risks, and adverse trends
  • Apply appropriate statistical tools and data visualization techniques to evaluate complaint data across products, failure modes, and geographies
  • Establish alert thresholds, escalation criteria, and signal validation processes
  • Support inspections, and audits with defensible trending analyses and documentation
  • Author or review SOPs, work instructions, and templates related to trending and post-market surveillance
  • Partner with Complaint Handling, CAPA, and Risk Management teams to translate trend signals into formal investigations and actions
  • Collaborate with Medical Safety, Clinical, and Regulatory teams to evaluate patient safety and reporting impact
  • Present trending results and risk assessments to management, governance boards, and quality review councils
  • Serve as SME for complaint data systems and analytics tools (e.g., validated QMS systems, dashboards, and reporting platforms)
  • Ensure data integrity, consistency, and traceability across complaint datasets
  • Develop standardized dashboards, trend reports, and executive summaries
  • Interpret and analyze complex data sets and clearly communicate findings to both technical and non-technical stakeholders
  • Monitor industry best practices and regulatory guidance related to complaint trending and post-market surveillance
  • Identify process improvements to enhance early signal detection, efficiency, and compliance
  • Mentor and train colleagues on trending methodologies and regulatory rationale

MINIMUM QUALIFICATIONS
  • Bachelor's degree in Engineering, Life Sciences, Biostatistics, Data Analytics, or a related field
  • Minimum 5-8 years of experience in medical device quality, complaint handling, post-market surveillance, or safety analytics
  • Demonstrated expertise in complaint trending, signal detection, and root cause analysis
  • Strong knowledge of global medical device regulations (FDA, EU MDR, ISO standards)
  • Advanced analytical and problem-solving skills with the ability to interpret complex data
  • Proficiency with statistical software or data visualization tools (e.g., Minitab, Power BI, Oracle, TrackWise)
  • Strong knowledge of global medical device regulations (QMSR, EU MDR, ISO 13485, ISO 14971)
  • Experience presenting to internal leadership as well as regulators/auditors.

Preferred Qualifications
  • Advanced degree preferred

Additional Qualifications
  • Strong oral and written English communication skills and effective interpersonal skills.
  • Experience in FDA-regulated environment.
  • Strong collaboration skills and experience working in a matrix environment.
  • Ability to multitask, prioritize and meet deadlines.
  • Proficiency in Microsoft Office (SharePoint, PowerPoint, Word, Excel, Adobe Acrobat, etc.) is required.

Salary Pay Range:
$81,650.00 - $112,700.00 USD Salary
Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour recruiter can share more about the specific salary range for your preferred location during the hiring process.
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.
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