Medical Device Complaint Trending Expert (Any Facility)

About the role

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Think differently, challenge what's possible, and make headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

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
• Serve as SME for complaint data systems and analytics tools (e.g., validated QMS systems, dashboards, and reporting platforms)
• Mentor and train colleagues on trending methodologies and regulatory rationale

Requirements

• 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
• Excellent written and verbal communication skills
• Strong knowledge of global medical device regulations
• 21 CFR Parts 803 and 820 / QSR and QMS
• REU MDR (Articles 83-86)
• MDSAP and ISO 13485
• ISO 13485 and 14971
• Experience presenting to internal leadership as well as regulators/auditors

Qualifications

• Advanced degree (MS, MBA, or equivalent)
• Proficiency with statistical software or data visualization tools (e.g., Minitab, Power BI, Oracle, TrackWise)
• Experience working with global complaint databases and high-volume product portfolios

Skills

• Strong oral and written English communication skills
• Effective interpersonal skills
• Experience in FDA-regulated environment
• Strong collaboration skills
• Ability to multitask, prioritize, and meet deadlines
• Proficiency in Microsoft Office (SharePoint, PowerPoint, Word, Excel, Adobe Acrobat, etc.)

Benefits

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)).

Pay

$81,650.00 - $112,700.00 USD Salary

Schedule

Not specified