78 applicantsPosted by Agency
Phaidon International · 3 days ago
Quality Assurance Specialist
Pennsylvania, United States
Contract
Hybrid
Mid Level
2+ years exp
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Responsibilities
Investigates complaints to determine complaint cause, completes Medical Device and Vigilance Reporting in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting.
Performs and/or coordinates complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports.
Evaluates all information from a technical perspective to ensure appropriate Analysis and Investigation.
Meets minimum productivity expectations for investigating assigned complaint category.
Reviewing peer investigations to support final closures.
Qualification
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Required
Bachelor’s Degree
Minimum of 2 years of experience in Quality Assurance with complaint processing role
Previous experience in medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR
Must demonstrate the ability to investigate complaints with minimal guidance
Strong problem-solving skills, critical-thinker, and experienced at investigating and resolving complex issues
Understand basic principles of good technical writing skills
Attention to detail and timeliness are critical
Excellent communication (verbal and written) and interpersonal skills required
Demonstrated experience with MS Word, Excel, Adobe Acrobat and other commonly used software systems
Must be able to work under minimum supervision and in a team environment
Must be a positive and energetic team player
Preferred
Background with firmware/hardware related complaints investigation a plus
Basic knowledge of Quality Systems (CAPA/non-conformances/SCARS) a plus
Company
Phaidon International
We have a clear strategy and it is working to deliver us competitive advantage and superior financial results.
1,001-5,000 employees
Funding
Current Stage
Late StageTotal Funding
$26.17M2022-07-18Acquired· by Further Global Capital Management
2016-04-27Series Unknown· $26.17M
Leadership Team
James Slipper
Group CFO
Andrew McNeilis
Managing Director Asia Pacific
Recent News
2024-05-19
Company data provided by crunchbase
