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Senior Quality Engineer - Process Validation - 100% Remote

Genesis10
life insurance, 401(k)
United States, Wisconsin, Neenah
Jan 10, 2025
Genesis10 is currently seeking a Senior Quality Engineer - Process Validation with our client in their Neenah, WI location. This is a 12-month + contract and 100% remote position.

Compensation: $33.00-38.00 per hour, W2.


Summary:

Seeking a highly motivated candidate with technical skills in problem-solving, critical thinking and who is detailed-oriented.

Responsibilities:


  • 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.


Requirements:

  • 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.
  • Only candidates available and ready to work directly as Genesis10 employees will be considered for this position.



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.



Pay rate range: $33.00 - $38.00 hourly

If you have the described qualifications and are interested in this exciting opportunity, please apply!

Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.

For contract roles, Genesis10 offers the benefits listed below. If this is a perm-placement opportunity, our recruiter can talk you through the unique benefits offered for that particular client. Benefits of Working with Genesis10:


  • Access to hundreds of clients, most who have been working with Genesis10 for 5-20+ years.
  • The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years.
  • Access to an experienced, caring recruiting team (more than 7 years of experience, on average.)
  • Behavioral Health Platform
  • Medical, Dental, Vision
  • Health Savings Account
  • Voluntary Hospital Indemnity (Critical Illness & Accident)
  • Voluntary Term Life Insurance
  • 401K
  • Sick Pay (for applicable states/municipalities)


For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others. To learn more and to view all our available career opportunities, please visit us at our website.

Genesis10 is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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