Quality Engineer IV

Summary:

Quality Engineer IV – Supplier Quality is responsible for Supplier Quality Management.  Primary contact with suppliers on all quality related issues during both the supplier maintenance and supplier selection process.  Responsible for overseeing supplier quality management activities and continuous improvement initiatives with suppliers. 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 program.
• Maintain Approved Vendor List.and Supplier Files
• 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.
• Lead Supplier audits and ensure suppliers implement and maintain any resulting corrective actions.
• Responsible for driving continual process improvements with suppliers through Supplier Corrective Action Requests.  
• Evaluate and recommend improvements in receiving and in-process inspection methods, equipment, and sampling plans.
• Establishes and maintains supplier quality metrics, scorecards, and trending.  
• Maintains compliance of Supplier Quality Management system to internal procedures, standards and regulations.
• Perform internal audits and other related duties as assigned.
• Ability to travel 40% of the time.

Qualifications:

• Bachelor’s degree in engineering (mechanical, industrial, chemical, electrical), or other technical discipline, or advanced degree in other disciplines, or equivalent experience preferred with at least 15 years in a regulated medical device industry.
• Minimum of 7 years of quality engineering experience in FDA regulated medical device manufacturing environment(s).
• Proficiency in reading and interpreting mechanical drawings and GD&T.
• Knowledge of QSR and ISO 13485.
• Medical Device Auditor certification preferred.
• Problem solver.
• Self-directed.
• Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.

Additional Requirements:

• 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 which ZELTIQ complies.

Language and Verbal Skills:

Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.

Math Skills:

Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Analytical and Reading Skills:

Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.  

Physical Requirements:

The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment:

Most work is performed in an office-like setting.  The noise level in the environment is usually low to moderate. 

Safety:

Zeltiq is committed to the health and safety of our employees.   We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.