Jan 14, 2025

Senior quality engineer - process validation

Job Description

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