Senior Quality Engineer

Position Summary:

As a Senior Technical Quality Engineer, you will be responsible for managing processes and leading projects to maintain and improve the quality system in accordance with applicable regulatory standards.  Ensure products and services are developed, manufactured, tested and delivered according to the established procedures.  Provide quality engineering support in the areas of project engineering, deviation management, change control, internal auditing, quality trending, continuous improvement, training, corrective and preventive actions, process control, calibrations, and documentation control.  Perform all duties using safety conscious practices.

Primary Duties:

1. Provide quality engineering support to manufacturing, maintenance, calibration, facilities, and project engineering departments.
2. Conduct root cause analysis, leads process corrective actions and other problem-solving activities.
3. Develop and implement statistically valid design of experiments (DoE), capability studies, SPC and trend analysis in support of products and service improvements
4. Provide periodic trend reporting as required (QSMR, Continuous Process Verification).
5. Conduct risk assessments, reviews/revises existing risk assessments through process feedback, and acts as quality representative for risk management activities
6. Use data to perform statistical analysis and recommend process / product changes to improve product quality
7. Provide quality support and approval signatures for Validations, Qualifications, Engineering/Scientific Studies and Technical Assessments as required.
8. Support Change Control Processes through assessment of system changes and execution of activities as needed.  Support CAPA, investigations, NCs, Waivers as QA function.  Review Bill of Material (BOMs), Assembly Procedures, Standard Operating Procedures, Drawings, and Component Specifications.
9. Perform periodic reviews on equipment and processes as needed
10. Review and approve calibration exception investigations, change controls, and first article inspections.  Participate in QA oversight activities for production, IND, MES, calibration, maintenance, and facilities. 
11. Participate in regulatory and agency inspections, audits, and investigations. Also participates in the site Internal audit and compliance review programs.
12. Participate in site CAPA activities, including analysis of data and trends, nonconforming material, complaints, training effectiveness, and root cause analysis.  Coordinates the implementation of corrective actions and preventive measures as needed.

     13. Support continuous improvement projects as needed.

Position Requirements:

1. Bachelor's Degree in a scientific field 

2. 5+ years of experience in a lab, validation and/or quality role. 

3. Medical device or other FDA regulated industry experience preferred

4. Must possess effective written and verbal communication skills.
5. Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
6. Must have a working knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (MDSAP, 21CFR820, ISO 13485, QSR, etc.).

       6.  ASQ Certification in one of the following is preferred:  CQE, CSQE, CRE, CQA, CBA, or Six        Sigma Green Belt.

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