Posted in Compliance 13 days ago.
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Type: Full Time
Location: Irvine, California
FIELD ASSURANCE SPECIALIST
Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.
This position is responsible for the ongoing administration, supervision and continuous improvement of Quality Systems to ensure compliance with US, European, Canadian, and international regulatory compliance and complaint handling/device reporting requirements. This position also is responsible for the timely completion of assigned activities related to regulatory compliance support activities worldwide.
* Serves as a primary contact for customer experience reporting and complaint handling activities related to Endologix products.
* Responsible for ownership of product complaints, including:
* Receiving complex medical procedure information (type of procedure performed, types of devices used, patient condition and any complicating factors, etc.) and asking probing questions to ensure the full picture of what occurred is captured
* Documenting the events that occurred in such a manner as they are chronological and make sense to a variety of readers
* Investigating complaint information received such as obtaining medical records and images, coordinating retrieval of returned devices and working with customs if necessary.
* Developing and writing responses to customers for product complaints. Take complex medical procedure information and determine the course of events related to each complaint and write investigation findings in response to customer inquiries.
* Ensures timely and accurate reporting regarding FDA MedWatch requirements as well as European Vigilance reporting requirements and other countries that Endologix product is sold in. Determines if serious injuries or malfunctions have occurred and, if so, whether or not they are reportable events.
* Collaborates with RFA to ensure timely evaluation of product complaints and timely completion of reports with this information to regulatory bodies.
* Develops good working relationships and collaborates with Sales personnel, Customer Service, Engineering, Manufacturing, Quality Assurance, Clinical Affairs, EU Representative, distributors and physician users in these investigations.
* Maintains current and complete complaint files.
* Identifies and contributes to or leads process improvement projects within the Field Assurance processes.
* Ensures applicable domestic and international regulations related to Risk Management and Medical Device Reporting are met.
* Prepares reports for periodic management reviews, as needed
* Perform other duties as assigned by supervisor
Bachelor s degree in a scientific discipline or equivalent.
* Minimum of 3-5 years of experience in complaint handling in the Medical Device industry.
* Knowledge of medical device regulations.
* Knowledge of quality systems and relationship to business.
* Ability to facilitate customer complaint investigations.
* Must demonstrate technical writing ability.
* Good interpersonal skills including ability to interact with high degree of diplomacy.
* Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
* Facilitate the timely closure of complaint investigations.
* Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
* Effective problem solving techniques and excellent applied thinking skills.
* Strong communication and organization skills required.
* Experience with Microsoft Office applications.
* Experiences with TrackWise is preferred.
Specific Skills, Knowledge & Behaviors
(To perform the job successfully, an individual should demonstrate the following competencies):
* Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately
* Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills
* Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals
* Prioritization: Effectively prioritizes work to ensure timely completion of work within scope
* Global & Systems Thinking: Continuously seeks to learn about and embrace global nuances, works across functions and geographies, seeks to align with diverse groups, and seeks to understand interdependencies and impacts of actions across functions and the company
* Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope
* Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self
* Problem Solving & Problem Prevention: Learns and uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention
* Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility
Equipment Use & Abilities Required:
* Equipment Use: Copy machines, fax machines, calculators and personal computers and computer terminals.
* Computer Skills: Software proficiency in Microsoft Office Suite.
* Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
* Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
* Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
WORK ENVIRONMENT & PHYSICAL DEMANDS OF THE JOB:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee