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Quality Engineeer II

Menlo Park, CA

Posted: 12/23/2019 Employment Type: Direct Hire Industry: Medical Device Job Number: j-4060

Job Description

SUMMARY:

Quality Engineer II represents the QA department from early design stages to production implementation/commercialization.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following (other duties may be assigned as necessary):

  • Represents the QA Department from early design stages to product implementation in manufacturing.

  • Independently develops the Quality plan and Quality strategy for each product development stage.

  • As a project team member, the individual will be responsible for leading the development of product specifications, Hazard Analysis, FMEA, test methods, test equipment and fixturing, engineering / clinical builds.

  • Creates quality documentation and coordinates biocompatibility, useful life studies.

  • Oversees design verification testing and leads test method improvement activities.

  • Oversees Design validation and/or Usability validation testing and documentation.

  • Independently designs experiments, develops protocols, performs process validations and data analysis, draws conclusions and communicates results.

QUALIFICATIONS:

Must have strong knowledge of medical device GMPs and ISO standards applicable to the FDA and international regulatory agencies. Superior time management, ability to work on several projects simultaneously, strong statistical skills and excellent communication skills required.

Additionally, must have a strong understanding of regulations and applicable standards. Also needed are

  • Working knowledge of EN ISO14971, QSR, ISO13485

  • Strong analytical and problem-solving skills;

  • Excellent verbal and written communication skills.

  • Strong interpersonal skills and the ability to work with cross-functional teams.

  • Strong background in statistics and working knowledge of Statistical data analysis

  • Working knowledge of Six Sigma, Project Management principles a plus.

EDUCATION and/or EXPERIENCE:

BS degree with a minimum of 3 years of experience in medical device product development or Advanced degree with a minimum of 1 year of experience in medical device product development.

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