Senior Quality Engineer Zeltiq Aesthetics, Inc.
THIS JOB HAS EXPIRED Description
Quality Engineer in charge of receiving inspection and Supplier Management. Primary contact with suppliers on all quality related issues during both the supplier maintenance and supplier selection process. Responsible for overseeing supplier management activities and continuous improvement initiatives with the supplier. Qualify suppliers according to company requirements. Monitors parts from acquisition through inspection.
Essential Duties and Responsibilities include the following (other duties may be assigned.):
? Manage and maintain the ZELTIQ supplier quality management.
? Develop and prioritize an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure GMP's, ISO 13485, and company?s quality standards are met.
? Conduct Supplier audits and ensure supplier implements and maintains any resulting corrective action program.
? Responsible for driving continual process improvement within the receiving inspection group.
? Evaluate and recommend improvements in receiving and in-process inspection methods, equipment, and sampling plans.
? Establishes and maintains metrics and trending.
? Maintains compliance to internal procedures, FDA, ISO and Canadian medical device regulations.
? Ability to travel 50% of the time.
? Perform other related duties as assigned.
? Bachelors degree in engineering (mechanical, industrial, chemical, electrical) or other technical discipline preferred.
? Minimum of 3 years of quality engineering experience in FDA regulated medical device manufacturing environment(s).
? Proficiency in reading and interpreting mechanical drawings and GD&T.
? Experience with medical device adverse events, complaint trending and CAPA systems.
? Knowledge of QSR, ISO 13485.
? Medical Device Auditor certification.
? Problem solver.
? Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
? Ability to program vision measure systems.
? Knowledge of quality/continuous improvement tools (SPC, Statistics, DOE, Six Sigma)
? 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.
? Ability to define problems, collect data, establish facts, and draw valid conclusions.
? Ability to read technical literature and documents and extract important concepts.
? Responsible for performing all duties in compliance with FDA?s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.
||Pleasanton, CA |
THIS JOB HAS EXPIRED