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Quality Complaints Specialist LDR Spine USA, Inc.
THIS JOB HAS EXPIRED
Job DescriptionMust work to ensure compliance with 'Regulations' (e.g., QSR), 'Standards' (e.g., ISO 13485), and the Quality Manual.
Assist with continuous improvements of Quality System for LDR Spine USA as well as international LDR offices.
Primary contact for all customer event reports and complaint handling activities, including independently receiving, documenting, investigating, and coordinating responses on product complaints.
Ensures timely investigation, documentation, and response to product complaints. This includes collaborating on the investigation, independently documenting reported information, and communicating outcomes.
Maintain current and complete complaint logs.
Communicates with vendors regarding complaints.
Periodic trending/analysis of product complaints and presentation to management.
Preparation of reports on complaints for single event analysis, cumulative analysis for regulatory submission, and management review meetings.
Responsible for timely decision making regarding MDR.
Other duties as assigned.
Desired Skills & Experience
Relevant degree in physical/ mathematical/ applied science,. Newer life science subjects, such as biotechnology, may also be advantageous.
Bachelor's degree in science, math, business or medical fields is preferred.
Minimum of 3 years of relevant experience in quality assurance/quality systems.
2 years experience in medical device environment is preferred, specifically in orthopedics/spine.
2 years experience with USA Quality Systems Requirements, complaint handling is preferred.
Working knowledge of FDA QSR/GMP requirements, and ISO 13485
Experience fielding complaint reports, coordinating and document product investigations, and root cause analysis.
Experiencing working in multi-functional teams including marketing, engineering, quality, regulatory, and sales.
Strong communication and organizational skills required. Must have a passion for details and demonstrate problem-solving skills.
Ability to exercise judgment and decision making within generally defined policies and/or regulatory guidance in selecting methods and techniques for completing tasks.
Expertise in Microsoft Office applications required. Familiarity with Quality Systems software preferred (Trackwise, Master Control).
| Location: | 13785 Research Boulevard Suite 200 Austin, TX 78750 United States |
|---|---|
| Full Time | |
| QA Testing / Quality Control | |
| quaility assurance FDA engineering regulatory |
THIS JOB HAS EXPIRED
LDR Spine USA, Inc.
LDR works closely with surgeons to develop implantable spine systems and instrumentation that restore optimum stability and mobility to patients and to make spine surgery more reproducible and easier to perform. More information is located at www.ldrholding.com.
Shipping Product 
> 50M RaisedInvestors: Austin Ventures, PTV Sciences, Rothschild Private Equity, Telegraph Hill Partners
All Jobs: at LDR Spine USA, Inc.
| Web Site: | www.ldrholding.com |
|---|---|
| Headquarters: | 13785 Research Boulevard Suite 200 Austin, TX 78750 United States |
| Employees: | >100 |
| 2004 | |
| Industry: | Medical Devices and Equipment |
| Vision: LDR combines passion and innovation to improve spine care. Mission: LDR develops and markets total spine solutions for patients and the surgeon community worldwide. We listen to surgeons and use our technical experience and passion for improvement to create innovative spine products. Founded: 2001- LDR Medical, SAS 2004- LDR Spine USA, Inc. 2006- LDR Holding Corporation Ownership and Financing: Private, Series-C Primary Investors: Austin Ventures, PTV Sciences, Rothschild Private Equity and Telegraph Hill Partners |
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