Job Description
Job DescriptionQuality EngineerResponsible for performing various Quality Engineering activities whose main purpose is to facilitate continuous improvement for both products and processes and to support new product/process development activities. These activities include process validation, defect analysis and corrective action, new product evaluation, performing internal audits to verify compliance with ISO and FDA/QSR Regulations, personnel training, and developing and implementing improved test and measurement techniques.Responsibilities:
- Oversight of various quality systems including, but not limited to, nonconforming material, audits, management review, external standards, and/or document management.
- Identification of quality issues and resolution support.
- Review of test protocols and/or process validation protocols and reports.
- Preparation and analysis of quality data and metrics.
- Support of internal audits of systems, products and processes.
- Preparation and support of external/regulatory audits.
- Preparation of engineering changes.
- Provide training and direction to manufacturing and QA personnel.
- Participate in MRB meetings.
- Support nonconforming material disposition.
- CAPA maintenance including investigation support, and/or corrective action ownership.
- Support quality/manufacturing related improvement efforts.
- Must be an independent worker, capable of meeting goals and objectives as defined by Management.
- Awareness of practices and processes utilizing current management tools.
Qualifications:
- BS Degree in a Technical /an Engineering discipline.
- Three years’ minimum experience within a manufacturing environment, with experience in manufacturing, quality, or process engineering preferred. Medical device experience preferred.
- CQE certification a plus.
- Must have knowledge of ISO 13485 and FDA/QSR Regulations.
- Strong computer skills with software applications for Microsoft Windows including Excel, Word and Minitab.
- Knowledge of Six Sigma and Lean manufacturing preferred.
- Ability to communicate effectively with personnel at all levels both verbally and in writing.
- A self starter able to function independently with minimum direction.
Pay Rate:$35-$44/hour