Quality Engineer
Department: Quality Assurance
Reports To: Quality Director
Posted On: 2/3/2010

SUMMARY
Provides expertise in support of the quality system and product development through project oversight, design and document review, testing, data collection and analysis, problem solving, verification, validation, audit, training, and reporting.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
  • Contribute to the establishment, operation, and maintenance of the Quality System.
    1. Development and documentation of quality plans, processes, procedures, and work instructions.
    2. Perform functional Quality System activities for inspection and test, process control, equipment calibration, nonconforming material, corrective and preventive action, quality records, and statistical techniques.
  • Provide quality support to the product development effort
    1. Establish product quality requirements and participate in design reviews.
    2. Responsible for product risk management system; plans, hazard analysis and FMEA / FMECA.
    3. Engineer responsible for maintenance of Regulatory Standards that apply to the product being developed, including maintenance of the essential requirements matrices.
    4. Participate in component, assembly, system, and process verification and validation. Perform process capability analysis.
    5. Participate in supplier selection, audit, and management.
    6. Participate and/or lead a Six Sigma Continuous Improvement Team
  • Provide quality support for marketed products
    1. Establish and maintain product quality measures, monitor product reliability, and contribute to improvements.
    2. Support inspection and test activities as required
    3. Perform product failure investigations and facilitate required corrective / preventive actions
    4. Principal member with QA-MRB Authority for the marketed products
  • Produce/maintain metrics and/or reports on all activities as required.
  • Stay up-to-date on and comply with procedures related to the job that can affect the quality of products or services provided to Company customers and assist in maintenance of favorable company regulatory compliance status.
  • Serve as a resource for quality requirements.
  • Assist in QA department training programs for Company personnel.
  • Perform other related tasks as required.
SUPERVISORY RESPONSIBILITIES
Direct Reports: None

QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Knowledge of quality system principles; FDA Quality System Regulation (cGMP); ISO 9001 / 13485 quality system standards; requirements for product development in a regulated environment, including design control, hazard analysis, validation, and process metrics.
  • Knowledge of ISO14971 Risk Management Systems required.
  • Software development and validation working knowledge a plus.
  • Ability to work with development engineers and other functional group personnel to accomplish common goals.
  • Detail oriented, with good written and verbal English communication skills.
  • Computer literate in word processing, spreadsheets, data bases, and other quality related productivity programs. Application of statistical techniques for quality assurance.
EDUCATION and/or EXPERIENCE
Requires BS / BA in an engineering, technical, or science field. Specific knowledge of quality assurance principles, product development, and manufacturing processes. ASQ Certification - CQE, desired. Requires 5 - 10 years QA/QC engineering experience in a product development and manufacturing environment, 5 years minimum experience with medical devices.
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Please submit your resume with cover letter to:

Cytori Therapeutics, Inc.
Human Resources Department
3020 Callan Road
San Diego, CA 92121
USA

Tel: +1.858. 458.0900
Fax: +1.858.458.0994
Email: jobs@cytoritx.com