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.
