Staff Quality Engineer

Staff Quality Engineer

08 Apr 2021
California, San diego, 92103 San diego USA

Staff Quality Engineer


The Staff Quality Engineer independently applies expert insight, experience, knowledge and skill, as well as implements, determines and develops best practices and procedures, to support complex and unique quality-related engineering activities (including, but not limited to, product development, verification and validation) and to solve multifaceted and critical quality issues that relate to the implementation, maintenance and support of new and existing products. The Senior Staff Engineer also works to contribute to the development of company objectives and principles and to achieve business goals.


  • Function as quality expert for all product development activities by providing quality planning and guidance that ensures compliance with design controls, robust testing and assurance of quality; continual identify and implement improvement activities to enhance the quality system, processes, products and standards by applying expert use of quality tools and statistical analysis

  • Define and implement processes for the early identification, correction and prevention of process and product quality non-conformances

  • Develop and implement process controls for new products and for transfers to manufacturing

  • Plan, develop and validate robust test methods which ensure acceptability of products under test

  • Provide leadership and guidance in production process optimization through the planning of activities (process mapping, data gathering, process analysis, validation, and the documenting of results)

  • Develop and implement statistical process controls and sampling plans

  • Write, review and approve validation protocols for new products, processes and equipment, ensuring systems, utilities and processes comply with regulations standards

  • Mentor team members as needed, particularly in the areas of data analysis and interpretation as they relate to quality assurance

  • Conduct and document root cause investigations in a systematic manner; ensure identified causes and associated corrective actions will reduce or eliminate sources of non-conformance

  • Participate in internal and external audits

  • Implement the analysis of risk at all phases of product development and production to ensure the safety and efficacy of company products

  • Maintain and advance and up-to-date knowledge of Quality Systems Regulations and other relevant quality principles, regulations and standards


  • Bachelor's degree, or equivalent, plus a minimum of ten (10) years previous experience, preferably within a regulated medical device or pharmaceutical environment; post graduate degree, or equivalent, preferred

  • Previous experience working on projects and issues that significantly impact the overall success of an organization a plus

  • ASQ certification and/or Six Sigma Green/Black belt strongly preferred

  • Experience with new product development (medical device or pharmaceutical) preferred

  • Expert knowledge of quality engineering principles required

  • Expert knowledge of Quality System Regulations required

  • In-depth practical experience with process and product quality, statistical sampling and analysis, design of experiments (DOE) gage R&R, ANOVA and validation required

  • Superior technical writing skills required

  • Superior communication and presentation skills

  • Knowledge of Microsoft Office required; knowledge of statistical software, and experience with large enterprise resource planning (ERP) system required

  • Superior planning and organizational skills required

  • Must be self-motivated and have the ability to work with minimal supervision; must also be able to work as part of a team

  • A demonstrated excellence of problem-solving skills required

Sthree US is acting as an Employment Business in relation to this vacancy.

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    USD $60 - $70 per hour 60 - 70 per hour
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