Engineering - Senior Quality Engineer - Process Validation
Engineering - Senior Quality Engineer - Process Validation
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Salary Not Disclosed
1 Vacancy
Job Description
Seeking a highly motivated candidate with technical skills in problemsolving critical thinking and who is detailedoriented. Provide support to our internal Test Method Validation team under the leadership and guidance of trained team members. Work in support of Quality system improvement initiatives remediation of quality system documentation design documentation standard and technical Test Methods etc. Support the TMV process for Variable and Attribute Physical test methods for products under the Feminine Care categories. The candidate will interact remotely with the research and engineering and mill laboratory locations for test execution and surrogate development as well as the execution of validation studies.
Basic Qualifications
1. Candidate must possess a bachelors degree in engineering or a scientific or quality assurance discipline.
2. Awareness of Design controls and change controls for FDA regulated medical devices (21 CFR 820.20 and ISO13285 standards)
3. Awareness of Test Method Validation Installation Qualification and related Statistics: Study design DOE TM Characterization Data Analysis (Gage R&R Correlation etc.) Test method validation study.
4. Ability to create technical documentation including TMC IQ TMV and Generic Verification protocols and reports.
5. Understanding of test fixtures and test equipment such as tensile frames.
6. Excellent written and oral communications. Ability to summarize and consolidate data and information in presentation form for crossfunctional discussion.
7. Ability to work remotely with advance proficiency in software applications: MS Office (Outlook Word Excel PowerPoint and MS Teams).
8. Ability to work autonomously across functional boundaries to complete projects within required timeframes while being part of a team.
Preferred Qualifications:
1. Experience in ETQ as a quality system
2. Product Knowledge of Tampons
3. Additional Experiences with Process Validation Risk Management and Quality systems.
4. Knowledge on Test Method Development and Validation: Surrogate development and Equivalence test
Employment Type
Full Time
