Akkodis · 17 hours ago
Complaints Engineer - Medical Device
United States
Contract
Remote
Entry Level
$42/hr - $44.44/hr
1+ years expAkkodis is seeking a Medical Device Complaint Engineer for a 6-month remote contract job with a medical device manufacturing client. The role involves managing the complaint handling process for medical devices, ensuring compliance with regulatory standards, and contributing to product improvements.
Information Technology & Services
Hiring Manager
Stephanie Lister
Responsibilities
Record, investigate, and analyze product complaints: Thoroughly document complaints, assess their severity and potential impact, and conduct investigations to determine root cause
Ensure Timely Closure: Manage complaint investigations and closures within established timelines and regulatory requirements
Adhere to FDA, ISO 13485, and other regulatory requirements: Maintain compliance with relevant regulations and standards for complaint handling and reporting
Identify and report adverse events and reportable complaints to regulatory agencies
Participate in product evaluations associated with field complaints: Assess the performance of devices in real-world settings and identify potential issues
Collaborate with cross-functional teams to identify and implement CAPAs to address root causes and prevent recurrence of issues
Analyze complaint data to identify trends and potential issues: Monitor complaint patterns and report key metrics to relevant stakeholders
Prepare and present reports on complaint trends and investigation outcomes: Communicate findings to management and cross-functional teams
Work closely with engineering, manufacturing, clinical, and other relevant teams: Collaborate effectively with various departments to investigate and resolve complaints
Ensure clear and concise communication of complaint information and investigation results
Qualification
Required
Bachelor's Degree in Engineering or a related scientific field
1-3 Years of previous complaints experience required
Experience in quality assurance and complaint handling
Knowledge of relevant regulations (FDA, ISO 1345)
Experience with root cause analysis tools and methodologies
Excellent written and verbal communication skills
Benefits
Medical
Dental
Vision
Life insurance
Short-term disability
Additional voluntary benefits
An EAP program
Commuter benefits
A 401K plan
Paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law
Holiday pay where applicable
Company
Akkodis
Akkodis provides digital engineering solutions for sustainable and innovative industries.
10001+ employees
H1B Sponsorship
Akkodis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (141)
2024 (121)
2023 (67)
Funding
Current Stage
Late StageLeadership Team
Lane Greever
Chief Operating Officer (COO), Americas
Kishore Raj
Vice President & Partner: Technology and Engineering Consulting and Services
Recent News
2025-11-10
Canada NewsWire
2025-11-06
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