Quality Engineer

San Diego, CA

Quality Engineer
$60,000-$85,000

RActively support the Quality Engineering department and all associated activities, including receiving inspection, in-process inspection, and finished goods inpsection in achieving and exceeding company goals and objectives. Support the administration, implementation, and continous improvement of the quality systems associated with corrective action, non-conforming materials, and inspection control lplans. This individual also supports corporate strategic goals and objectives through internal audits, support of manufacturing operations, quality support of new product development/product improvement projects, and support of manufacturing process improvement projects.

The Quality Engineer assists in determining, implementing and improving the evolution of the corporate quality control system, and its impact on both the strategic and daily product development and manufacturing operations. This individual is responsible for supporting the development and implementation of departmental policies and resources into the daily functions that will affect the long term quality and manufacturing culture and business strategies within the organization. This individual must lead the efforts in resolving varying levels of quality and compliance issues independently and/or in unison within a cross functional team environment to efficiently and effectively eliminate the issue and its cause.

• Prefer a B.S. in Engineering/Chemistry/Biology/Technical Discipline or equivalent combination of certification and work experience.
• 5+ years experience in Quality and Manufacturing Systems in Medical Device and high volume manufacturing environments.
• Quality Tools - Problem Solving / Statistical Process Control / Process Capability / ISO 9001 / ISO 13485 / Design of Experiments / Sampling Plans.
• Communication Skills - Ability to communicate effectively with all levels of employees throughout the organization. Able to develop and maintain strong working relationships with internal and external customers.
• Computer skills - proficient in Microsoft Office, statistical software programs, operation systems, voice and email, etc.
• Project management, multiple tasking and excellent prioritization skills.
• Knowledge of quality systems and regulations for medical device industry.
• The Quality Engineer should have a results oriented commitment to the continuing evolution of the quality control system within defined regulatory and corporate requirements. This requires a practical, common sense knowledge base and approach in developing, implementing and admnistrating the quality control system, especially as it relates to technical problem solving, implementation of corrective actions, development of statistical based inspection control plans and supplier management and direct material control.
• The individual must be technically knowledgeable with respect to quality systems, regulatory standards, supplier/subcontractyor management, manufacturing systems, product development, project management, material flows, and general production principles. The individual is responsible for supporting the implementation adn administration of departmental procedures that will affect the long-term quality and manufacturing strategies within the organization.
• Auditing experience and certification strongly preferred.
  

Please contact:

George Everett
858-277-1882 Office
858-699-2613 Mobile
george@crean-everett.com

May 7, 2009