Associate Quality Engineer

Required Qualifications

• Bachelor’s degree in engineering, science (with a focus on biology and/or chemistry), or a related field; or an associate degree in a related field with an additional two years of experience.

• 2+ years of experience in a manufacturing operations environment.

• 1+ years of experience applying quality principles and practices.

• Knowledge of and experience working within a 21 CFR Part 820, ISO 13485, ISO 9001, and/or cGMP-regulated environment.

• Strong communication and collaboration skills with the ability to work effectively across Operations and Quality teams.

• Ability to work onsite at least 90% of the time, travel between Madison locations, and travel up to 5% away from the work location, potentially including overnight or weekend travel.

• Ability to meet applicable PPE requirements and perform role-related physical activities, including lifting up to 40 pounds, with or without reasonable accommodation.

• Authorization to work in the United States without sponsorship.

What You’ll Work On

• Partner with Operations as a Quality representative to review production records, executed test methods, and material disposition decisions before commercial distribution.
• Review process and test method validation, equipment and facility qualification documentation, and calibration records; identify and resolve deficiencies before commercial use.
• Support nonconformance and deviation investigations, assess process risks, recommend mitigations, and help improve manufacturing and quality processes.
• Review and approve standard operating procedures and manufacturing work instructions, and conduct production-area audits to maintain compliance with cGMP, ISO, ICH, and internal quality standards.
• Collaborate with cross-functional teams to resolve day-to-day quality concerns, maintain accurate documentation, and support continuous improvement.