Quality Engineer

Quality Engineer - Product Development

As a Quality Engineer in Product Development, you will engage in engineering design services and related activities to ensure product compliance with safety regulations and quality standards. You will serve as a crucial partner for project teams and customers, providing expertise on safety agency and regulatory compliance, as well as advising on necessary quality systems.

• Work independently across multiple phases of the Product Realization Process without guidance from mentors or management.
• Ensure project activities are compliant with Standard Operating Procedures, applicable Quality Management Systems, and industry-specific regulations such as FDA, FCC, FAA, MDR, IVDR, REACH, and RoHS.
• Provide strategy and guidance to the development team on managing industry-specific safety standards such as IEC standards, tailored to each product.
• Direct the development and assembly of prototypes by authoring and reviewing product documentation in accordance with quality and change management procedures.
• Demonstrate expertise in Quality Management Systems, with required knowledge of ISO 9001 and preferred knowledge of AS9100.
• Determine specifications to comply with regulatory and compliance requirements of intended markets, and facilitate proper documentation of such specifications.
• Assist project management in developing proposals with accurate technical, staffing, budgetary, and scheduling content.
• Communicate effectively with internal and external customers via teleconference, email, and in-person interactions regarding project technical matters.
• Lead project teams through product risk management activities, including Hazard/Harm Analysis, Failure Mode and Effects Analysis, Fault Tree Analysis, and Cybersecurity risk assessments.

• Proven ability to work independently in various phases of the Product Realization Process.
• Deep understanding of Quality Management Systems, with required ISO 9001 knowledge and preferred AS9100 expertise.
• Proficiency in managing industry-specific regulations such as FDA, FCC, FAA, MDR, IVDR, REACH, and RoHS.
• Experience in developing and reviewing product documentation according to quality and change management procedures.
• Strong communication skills in teleconference, email, and in-person settings.

• Experience with industry-specific safety standards such as IEC standards.
• Experience in product risk management activities such as Hazard/Harm Analysis, Failure Mode and Effects Analysis, Fault Tree Analysis, and Cybersecurity risk assessments.

The role involves collaboration with project teams and requires interaction with both internal and external customers. The position demands expertise in managing regulatory compliance and quality standards, alongside effective communication skills across various platforms.

This is a Contract position based out of Neenah, WI.

The pay range for this position is $45.00 - $65.00/hr individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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)

This is a hybrid position in Neenah, WI.

This position is anticipated to close on Aug 21, 2026.

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