Quality Complaints Specialist LDR Spine USA, Inc.
THIS JOB HAS EXPIRED Job Description
Must 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).
THIS JOB HAS EXPIRED
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.
> 50M RaisedInvestors: Austin Ventures
, PTV Sciences
, Rothschild Private Equity
, Telegraph Hill Partners All Jobs: at LDR Spine USA, Inc.
|Headquarters:||13785 Research Boulevard|
Austin, TX 78750
|Industry:||Medical Devices and Equipment|
|Company Profile:||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.
2001- LDR Medical, SAS
2004- LDR Spine USA, Inc.
2006- LDR Holding Corporation
Ownership and Financing:
Primary Investors: Austin Ventures, PTV Sciences,
Rothschild Private Equity and Telegraph Hill Partners
Support LDR Spine USA, Inc. with Social Media services