Quality Engineer - Pierceton, IN - 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. 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 instruments and implants or instrument delivery systems as required. Lead or assist in leading multi-function continuous improvement activities.
- Represent company in meeting with Customers to fully develop their requirements or as required in the manufacture of contracted products.
- Assist in both internal and external audits of all corporate quality systems and demonstrate compliance through objective evidence.
- Support the creation and improvement of quality systems based on ISO 13485 and FDA requirements.
- Possible day-to-day supervision duties of quality technicians or inspectors.
- Be able to meet the visual acuity requirements (shades of color and color blindness).
- Be able to meet the requirements of the vision screening test (eye chart).
- Occasionally gauge R&R studies, train others in statistical techniques, and process control validations. Calibrate and control all gauges and measuring equipment used in production.
- Once employee demonstrates competency in position, he/she may be required to train other in similar roles.
BSQuality Engineering or related field.
3-5 years’ experience with tight tolerance measurement systems in machining applications, blueprint reading, GD&T, and a working knowledge of short run process control methods, DOE, ISO standards, and FDA quality system regulations.
Previous medical device experience preferred.