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Quality Engineer (manuf)

Job Title:
Link to apply:
Job city: Piercson

Type of job: Full Time (Salaried)

Job summary:


Doc 10047-52 Rev A


POSITION TITLE:  Quality Engineer  DEPT: Quality          
SUMMARY OF POSITION: Responsible for meeting customer requirements for the manufacturing of surgical instruments and implants or instrument delivery systems from receiving raw material through to the shipping of finished goods. Supports the development of and enforces internal systems and procedures to meet ISO standards and FDA quality system regulations. Develops and implements inspection/validation techniques necessary to verify products meet requirements at the earliest point in the production process. Specifies and implements new inspection equipment and instructs others in its proper use. Supports and implements systems in the areas of SPC, advanced quality, and design and development.
 Practical implementation of systems and procedures for meeting ISO standards and FDA quality system regulations.
 Supervise and train personnel in the inspection of raw materials, in-process and finished goods using statistical sampling techniques and precision measuring instruments to check conformance to requirements.
 Verify that all production procedures have been followed and the records such as Device Master Records and Device History Records are maintained per FDA and customer requirements.
 Design inspection/validation steps to be taken by operations at the point of manufacture and integrate these steps into the manufacturing instructions.
 Specify required inspection equipment and holding apparatus to accommodate repeatable measurements.
 Work in conjunction with Cell Leaders to ensure operators are knowledgeable and competent in the use and care of sensitive measuring equipment and related requirements such as calibration, recording of data, expected variability, etc.
 Assist/lead company Lean/6 Sigma initiatives to remove variability and reduce cost. Q.E. is responsible for ensuring cell processes are correctly base-lined and controlled. Known variability is to be accounted for through selection and frequency of inspection, sampling plans, or implementation of SPC.
 Assist in the inspection of surgical instr

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