Job Title: Senior Quality Engineer - Process Validation
Job Id: 25-05867
Location: Remote Role
Duration: 12 Months Contract[W2]
Position Type: Hourly Contract Position (W2 only)
- Position can be 100% remote.
- Candidates must possess a bachelor's degree in engineering, or a scientific or quality assurance discipline.
Job Summary/Description
- Seeking a highly motivated candidate with technical skills in problem-solving, critical thinking and who is detailed-oriented. 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
- Candidate must possess a bachelor's degree in engineering, or a scientific or quality assurance discipline.
- Awareness of Design controls and change controls for FDA regulated medical devices (21 CFR 820.20 and ISO13285 standards)
- 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.
- Ability to create technical documentation including TMC, IQ, TMV, and Generic Verification protocols and reports.
- Understanding of test fixtures and test equipment such as tensile frames.
- Excellent written and oral communications. Ability to summarize and consolidate data and information in presentation form for cross-functional discussion.
- Ability to work remotely with advance proficiency in software applications: MS Office (Outlook, Word, Excel, PowerPoint, and MS Teams).
- Ability to work autonomously across functional boundaries to complete projects within required timeframes while being part of a team.
Preferred Qualifications:
- Experience in ETQ as a quality system
- Product Knowledge of Tampons
- Additional Experiences with Process Validation, Risk Management, and Quality systems.
- Knowledge on Test Method Development and Validation: Surrogate development and Equivalence test
Qualified candidates please send your word format updated resume at the earliest to:
- Pavan: Pavan.p@sunrisesys.com [732-272-0382]
- Sangeeth: Sangeeth.k@sunrisesys.com [732-272-0281]
Thank you,
Sunrise Systems Inc.,
Sunrise Systems