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Quality Engineer

Sunnyvale, CA 94089

Post Date: 05/10/2018 Job ID: 8335 Industry: Software Engineer Pay Rate: Not Specified
We are looking for a Quality Engineer - Supplier/NPD will be responsible for quality engineering activities focused on instrumentation hardware. Primary responsibilities will be to support New Product Development (NPD) core teams through supplier quality engineering and NPD quality engineering duties.

Key Responsibilities:
* Supports and/or creates Quality Engineering documentation such as Quality Plan, Validation Master Plans and Reports.
* Participates in development projects by providing quality engineering services to assigned projects. Ensure defendable engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations.
* Provides project with guidance on sound design control strategy compliant with Quality System Regulations (QSR) and Quality Management Systems (QMS), supporting a product release that is safe and effective, meets intended use, and is sustainable in the field.
* Understands and applies the manufacturing quality toolset including NCR, SCAR, SRB, MRB, PFMEA, IQ, OQ, PQ, GR&R/measurement system analysis, control plans, process verification/validation plans, validation protocol development, Cpk, Cp, SPC, hard gauging applications, computer-based inspection methods, operator work instructions, DOE, process data analysis, and DMAIC.
* Reviews drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerancing (GD&T), proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods. Recommend revisions to assure design requirements are specified in the appropriate detail and clarity to provide a successful design transfer.
* Attends and guides product risk assessments, ensuring effective hazard identification, appropriate risk controls identification, and appropriate documentation of risk assessments
* Works with product support teams, engineering and others on component quality issues and supplier initiatives.
* Attends meetings and work effectively with extended teams which may include Manufacturing, Engineering, Research and Development, Quality, Regulatory and Marketing.


Preferred Requirements: * Knowledge of CFR 21 Part 820 (QSR), ISO 13485 * Experience in product mechanical evaluation & testing and GD&T * Prior FDA regulated medical device product development environment experience. * Experience with Minitab or similar statistical software * A quality engineering certification from the American Society for Quality (ASQ), or other qualifying organizations such as CQE, CRE, CQA. * Experience in the application of production and process controls including process validation, process control plans and statistical process control. * Bachelor's Degree in mechanical engineering, electrical engineering, industrial engineering or related discipline and a minimum of three to five (3 to 5) years related experience.

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