Quality Analyst Zeltiq Aesthetics, Inc.
THIS JOB HAS EXPIRED Description
Position Title: Quality Analyst
Description: The primary responsibility of this position is assisting in the management of the complaint system including the investigation, analysis, resolution, trending and corrective action of all complaints.
Specific responsibilities include; preparing and analyzing complaint trend data, maintaining the complaint files and supporting the resolution of complaint CAPAs to
closure and verification of CAPA effectiveness.
Other duties may be assigned.
Reports To: Manager, Quality Systems
Principle Responsibilities and Duties:
Note: The following is meant to be representative but not necessarily all-inclusive of the duties and responsibilities for this position.
Establishes and maintains complete complaint files for all customer complaints
Responsible for investigating complaints and/or managing resources necessary to investigate complaints to resolve both product/procedure issues determined through failure analysis, focusing on root cause analysis
Reviews and analyzes customer complaint information for trending/risk analysis and corrective action and resultant effectiveness of action
Interfaces with customer service and technical service and other groups on a daily basis to drive timely completion of complaints
May communicate directly with customer to resolve complaints
Applies systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving complaints
Maintains compliance to internal complaints procedure, FDA, ISO and Canadian medical device regulations
May assist in Internal Audits
Experience, Education, Training, Traits:
Bachelors degree in engineering (mechanical, industrial, chemical, electrical) or other technical discipline preferred or a minimum of 5 years relevant work experience
Minimum of 2 years of quality systems experience in FDA regulated medical device manufacturing environment(s) with 1 year in complaint system management Experience with MDR/Vigilance Reporting, complaint trending and CAPA systems desirable
Knowledge of QSR, 13485:2003, and 14971:2007
Certified internal auditor a plus
Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook
Language and Verbal Skills
Good oral and written communication skills.
Ability to write reports, data analysis, and business correspondence.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to clearly and concisely convey project accomplishments, obstacles, issues and status to project team members.
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.
Ability to use MS Excel to perform calculations and interpret results/data.
Analytical and Reading Skills
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to read technical literature and documents and extract important concepts.
||Pleasanton, CA |
THIS JOB HAS EXPIRED