o Seeking a highly motivated candidate with technical skills in problem-solving, critical thinking and who is detailed-oriented. Incremental 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, DHFs, DTMs, RTMs, etc. Lead the TMV process for Variable and Attribute Physical test methods for products under AFC categories. The work 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.
o On-site once offices reopen.
o Candidate must possess a bachelor's or advanced degree in an Engineering or Scientific discipline.
o Knowledge in Design controls and change controls for FDA regulated medical devices (21 CFR 820.20 and ISO13285 standards)
o Knowledge on Test Method Validation, Installation Qualification, and related Statistics: Study design, DOE, TM Characterization, Data Analysis (Gage R&R, Correlation, etc.), Test method validation study.
o Ability to create technical documentation including TMC, IQ, TMV, and Generic Verification protocols and reports.
o Knowledge on test fixtures and test equipment such as tensile frames.
o Excellent written and oral communications. Ability to summarize and consolidate data and information in presentation form for cross-functional discussion.
o Ability to work remotely with advance proficiency in software applications: MS Office (Outlook, Word, Excel, PowerPoint, and MS Teams), Connective applications (Zoom, MS Teams and Skype).
o Pro-active approach on project management, problem solving and development of Test Method Validation activities.
o Ability to work autonomously across functional boundaries to complete projects within required timeframes while being part of a team.
o Experience in ETQ as a quality system
o Product Knowledge of Tampons, Pessaries, menstrual pads, wipes, and/or incontinence products
o Additional Experiences with Process Validation, Risk Management, and Quality systems.
o Knowledge on Test Method Development and Validation: Surrogate development and Equivalence test