About The Team
The Quality team is an integral part of ensuring products, services, and processes are of the highest quality and meet customer and regulatory requirements. We are a team of detail-oriented professionals who take pride in meticulously assessing processes, products, and services to identify and rectify issues, ensuring the utmost quality and customer satisfaction. If you share our passion for maintaining the highest standards of quality and are dedicated to making a positive impact, we invite you to consider joining our Quality Assurance Team. Together, we can continue to elevate our organization's quality standards and provide unparalleled value to our customers and stakeholders.
A Day In The Life Of Our Manager, Complaints and Post-Market
Perform a wide variety of activities to ensure compliance with applicable quality and regulatory requirements.
Oversee day-to-day activities of the complaint handling team, ensuring complaints are handled promptly and accurately
Work closely with Product Quality Engineering team to ensure that investigations and complaints are completed and closed out in a timely manner
Review complaint files to ensure all complaint elements have been addressed and properly documented within the complaint file
Manage adverse event reporting activities including decision rationale and reporting documentation.
Submit adverse event reports to regulatory authorities
Manage complaint metrics and analytics including trending and measure against statistical trend limits
Schedule post market surveillance reviews and complete post market surveillance reports based on applicable regulatory requirements
Coordinate with clinical, marketing, sales, regulatory, and R&D to obtain their respective post market surveillance information based on regulatory requirements
Initiate risk file updates based on post market data such as complaint rates and new hazards
Review customer inquiries and service reports for potential complaints
Identify and escalate complaints for potential adverse event reporting decisions
Perform complaint case final reviews for closure
Manage complaint handling team activities and provide guidance as needed
Review, revise and create SOPs (Standard Operating Procedures) and/or WIs(Work Instructions) related to complaint handling, adverse event reporting
Prepare SOPs and WIs and gather data as needed to support ISO 13485:2016 clause 8.2.1 Feedback and for OUS regulatory requirements
Assist in audits (internal and external). May also conduct internal audits as needed.
Other QMS activities as assigned
About You
At minimum a BS degree in a technical field such as engineering, computer science, or a science related discipline.
5+ years of complaint-handling experience in the medical device industry.
Ability to manage others, their work, and your own multiple competing priorities.
Working knowledge of the entire complaint handling process from intake, investigation, closure, and reportability assessments.
Strong Working knowledge of US FDA 21 CFR 820.198, 803, and 806 requirements.
Basic Working knowledge of OUS adverse event reporting requirements.
Basic Working knowledge of OUS post market surveillance requirements.
Working statistical knowledge as it pertains to trending Intermediate understanding of mechanical and software aspects of medical devices.
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