Medical Murray is a leading OEM designer and manufacturer of complex, disposable medical devices. We are experiencing large growth in our Lake Zurich manufacturing operation and need additional quality engineering support. We are seeking an engineer to share the responsibility for Quality Assurance, Quality Engineering, Analysis, and ISO functions. This includes the following specific responsibilities:
- Supervise and perform testing and inspection activities.
- Maintenance of inspection records.
- Maintain gage calibration system.
- Perform internal audits.
- Provide quality and reliability engineering functions on product development projects (per ISO and FDA requirements).
- Train employees concerning quality standards.
- Develop and document control plans which define verifications during production to ensure all stated requirements are met.
- Work with production in support of validation and qualification studies.
- Support deployment of quality system procedures.
- Provide general quality support as required by management.
- Analyze nonconforming conditions in production to determine root cause.
- Communicate with process owners to resolve nonconforming conditions by developing or facilitating corrective and preventive actions.
- Summarize and report nonconformance information and evaluate trends and major causes.
- Plan and document studies of measurement repeatability and reproducibility; and process capability.
- Perform internal audits of the quality system and verification activities; and supplier audits as requested.
- Use inspection, measuring and test equipment as necessary.
- BS or MS in Engineering discipline.
- 3-5 years experience in Quality Engineering for medical devices or 5-8 years experience.
- Experience in the area(s) of Quality Systems.
- Knowledge and understanding of FDA QSR and ISO-13485 standards.
- Quality assessment/ audit experience desirable.
- Technical skills must include disposable medical device testing, protocols, analysis and report writing,
- Knowledge of statistics, for example experiment design and SPC.
- Computer skills needed include Microsoft Office or equivalent.
- Strong analytical and problem solving skills.
- Excellent verbal and written communication skills.
Indeed - 7 months ago