Job Summary

Sr. Hardware Quality Engineer

  • Location:
    San Diego, California
  • Job reference:
    US_EN_6_23945_59649201
  • Category:
    Quality Assurance
  • Contract Type:
    Contract/Temporary

Sr. Hardware Quality Engineer
San Diego, CA
 
Hardware Quality Engineering is responsible for participating in product development teams to support all quality aspects of design, development, and design transfer to manufacturing including supplier selection and qualification.
 
Sr. Quality Engineer is accountable for:
• Supporting new product development and product maintenance through the application of Quality engineering skills for medical devices.
• This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.
• Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements.
• Representing Quality on new product development and sustaining engineering projects.
• Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.
• Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and Good Manufacturing Practices (Auditor-in-Training)
• Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and lower level project developers
• Prepares/Revises policies/procedures.
• May be expected to make presentations
 
 
QUALIFICATIONS:
• Bachelor's degree in related field required
• 4+ years related work experience required
• Applies working knowledge of quality engineering concepts and test methods within the product lifecycle
• Understanding of test protocol structure and requirements.
• Applies basic knowledge of end user into test protocol
• Ability to select appropriate test methods and to develop test protocols and execute them.
• Ability to perform statistical analysis of results.
• Determines that quality objectives and goals have been identified and are sufficiently defined in specifications, procedures, and testing
 
 


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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Equal employment opportunity information:
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