Our team is partnered with rapidly expanding medical device manufacturer in Milwaukee, WI to bring on a Quality Engineer to join their team. The Quality Engineer will play a pivotal role in ensuring the continuous enhancement of operational processes and outputs in adherence to FDA and ISO standards. The ideal candidate will possess exceptional problem-solving abilities and a keen eye for maintaining consistent quality standards across all facets of the organization's operations.

Key Responsibilities:

Investigate complaints, non-conformances, and CAPA issues, and document findings. Use effective root cause analysis methods to drive investigations. Conduct internal audits according to ISO standards. Validate and approve Production Approval Processes (PAPs) and New Product Introduction (NPI) programs. Develop and write Quality Management System (QMS) documents, specifications, and work instructions.

Qualifications:

A Bachelor's degree in a scientific or engineering discipline or an equivalent combination of education and relevant experience. Demonstrated experience of 1-3 years in a Quality or Regulatory Affairs capacity. Proficiency in quality system standards is essential.