Senior Certified Quality Engineer SynCardia Systems
Senior Certified Quality Engineer
Department Name: Quality
Reports to: Director of Quality
Supervises: Quality Control Technician and Quality Technician
Essential Duties and Responsibilities
Implement cost of quality concepts, including quality cost categories, data collection, reporting etc. for manufacturing
Provide training and direction, as required, to other individuals in quality regarding conduct of product inspection, documentation reviews or incoming inspection methodologies and evaluations. Conduct inspections of components and subassemblies as required and document compliance to approved specifications and procedures
Initiate and coordinate laboratory testing of raw materials, assemblies, finished goods and environmental conditions.
Devise sampling procedures and designs and develop forms and instructions for recording, evaluating, and reporting quality and reliability data.
Schedule and conduct Quality system audits of material and service suppliers.
Coordinate and oversee sterilization validation activities.
Ensure systematic planning, and controlling of product and process quality in manufacturing
Processes for planning product and service development
Implement a validation program for new/changed materials, equipment, processes and components.
Support a systematic program for quality problem solving and continuous improvement in manufacturing
Implement and support quality improvement models
Corrective and preventive action
Overcoming barriers to quality improvement
Quality System Support
Complaint handling and investigation
CAPA handling and investigation
Returned heart program
Guidance for completion of failure investigations
Participation in external audits - develop responses to queries during and following the audit
Responsibility and Authority Affecting Quality
Initiate action to prevent the occurrence or potential occurrence of any nonconformities relating to the product, process and Quality System.
Identify and record any problems relating to the product, process and quality system.
Initiate, recommend or provide solutions through designated channels.
Verify the implementation of solutions.
Skills and abilities (required for the job)
Excellent communication and writing skills
Strong organizational skills
Ability to handle multiple tasks simultaneously
A team player
Education, experience and training (required for the job)
Master?s Degree in an Engineering/Biological Science discipline or equivalent
ASQ Quality Engineering Certification, or equivalent
Thorough understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics
Thorough understanding of a quality system and its development, documentation and implementation with respect to domestic and international standards and requirements.
Thorough understanding of the audit process, including types of audits, planning, preparation, execution, reporting results and follow-up
Ability to develop and implement quality programs, including tracking, analyzing, reporting and problem solving
Ability to plan, control and assure product and process quality in accordance with quality principles which include panning processes, material control, acceptance sampling, and measurement systems
Thorough knowledge of statistical analysis, reliability, maintainability and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting
Thorough understanding of problem solving and quality improvement tools and techniques, including management and planning tools, preventive and corrective actions, and how to overcome barriers to quality improvements
Ability to acquire and analyze manufacturing data using appropriate standard quantitative and statistical methods across a spectrum of business environments to facilitate process analysis and improvement
Minimum of five years? experience in a regulated industry or equivalent
Work Station Area: Office, Laboratory and Controlled Environment Manufacturing Area
Special Factors in the Work Area: None
The working environment is indoors and is seasonally heated and cooled with minimal noise levels.
The position requires considerable sitting, typing and the ability to move objects of less than 25 pounds.
The position requires the ability to communicate in person, telephonically and via email.
||1992 East Silverlake Road |
Tucson, AZ 85713