Job Title: Quality AssuranceJob Description

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

Responsibilities

• Support internal Test Method Validation team.

• Work on quality system improvement initiatives, including the remediation of quality system documentation and design documentation.

• Support the TMV process for Variable and Attribute Physical test methods for Feminine Care products.

• Interact remotely with research and engineering and mill laboratory locations for test execution and surrogate development.

• Execute validation studies.

Essential Skills

• Bachelor’s degree in engineering, scientific, or quality assurance discipline.

• Awareness of Design controls and change controls for FDA regulated medical devices (21 CFR 820.20 and ISO13285 standards).

• Knowledge of Test Method Validation, Installation Qualification, and related Statistics: Study design, DOE, TM Characterization, Data Analysis, 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 communication skills.

• Ability to summarize and consolidate data and information in presentation form for cross-functional discussion.

• Proficiency in 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.

Additional Skills & Qualifications

• Experience in ETQ as a quality system.

• Product knowledge of tampons.

• Experience with Process Validation, Risk Management, and Quality systems.

• Knowledge of Test Method Development and Validation: Surrogate development and Equivalence test.

Work Environment

This position can be 100% remote and follows standard first shift hours.

Pay and Benefits

The pay range for this position is $30.00 - $35.00

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position will be accepting applications until Jan 18, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.