Medical Device Quality Engineer
8 - 10 years experience • IT Consulting/Services
We are looking for Medical Device Quality Engineer for our client in Cornelia, GA
Job Title: Medical Device Quality Engineer
Job Location: Cornelia, GA
Job Type: Contract – 12 Months / Contract to Hire / Direct Hire
“US citizens and those authorized to work in the US are encouraged to apply. We are unable to sponsor H1b candidates at this time.”
- The Quality Engineer will utilize Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. This individual will utilize Quality Engineering principles and problem-solving skills to develop and optimize products/processes that are aligned with the overall Quality and Business vision. Ensure effective risk management to prevent unanticipated failure modes and ensure capability.
- The Quality Engineer will function as a project team member in matters relating to Quality Engineering. Ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, statistical process control, and development of sample plans. This individual will ensure the development of a comprehensive risk management plan for the product and process. This individual will ensure effective quality strategies for validation. Ensure the development and validation of appropriate test methods for product and process performance. Ensure effective and consistent application of Quality Engineering and Process Excellence tools and techniques. Additionally, this individual will ensure active and thorough investigation of quality issues and effective corrective and/or preventive action.
- The Quality Engineer will effectively utilize Process Excellence to solve problems and develop optimal products and processes. Ensure compliance with company policies and procedures. Provide guidance and recommendations involving the implementation of regulatory requirements (e.g. Quality System Regulations, EU MDD, ISO standards, etc.). Partner with Operations Engineering in the application of process validation, process control, and process risk management. Partner with Operations in the investigation/correction of process failures. Implement and monitor process capability for continuous improvement. Ensure effective change control and proactively communicate with DQE regarding any changes in design or changes in process that could affect product design.
- A minimum of a Bachelor's degree is required, preferably in Engineering, a Life Science, a Physical Science, Chemistry, or Business. A minimum of 7-10years of prior work experience in a Quality function is required.
- Experience leading and or facilitating Design of Experiments and Process Failure Modes Effects Analysis is preferred. Certified Quality Engineer (CQE) (ASQ or equivalent) is preferred.
- Process Excellence Certification, such as Six Sigma, Lean or Quality by Design Green Belt or Black Belt, is preferred. Knowledge of Process Excellence/Six Sigma tools and methodologies preferred.
- Knowledge of Lean Manufacturing and Manufacturing processes such as Just in Time (JIT), KANBAN and Pull Systems are preferred.
- Demonstrated knowledge and application of QSR - 21CFR820, MDD, ISO - 13485, ISO - 14971 and otherinternational standards are preferred.
- Experience with Geometric Dimensioning and Tolerancing is preferred.
- Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) required.
- Experience with Minitab, Visio and Microsoft Project is preferred. Effective technical writing skills are required. Knowledge of general statistics is required.
- Must have excellent communication and interpersonal skills. Must have strong analytical problem solving skills.
- The ability to collaborate with all levels of management in a cross-functional team environment is required.
- This position will be located in Cornelia, GA (approximately one hour from the Greater Atlanta area).
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