Quality Engineering Lead, Medical Devices (CQE/CRE)

Aequor; Warsaw (IN); On-site; USD 85,000 - 120,000; Full time

Job summary

Zimmer is seeking a Quality Engineer to ensure medical device quality from design through production. You will apply ISO/QSR standards, lead quality improvement projects, and collaborate with cross-functional teams to resolve issues and implement robust processes.

Ideal candidates hold a BS in engineering with a CQE/CRE, 5–7 years in quality engineering, and proven ability to drive deadlines and budgets while maintaining strong supplier relations.

Qualifications

• BS in engineering or equivalent with CQE/CRE preferred.
• 5–7 years in a Quality Engineering role, medical device exp preferred.
• Ability to communicate clearly with multiple departments and suppliers.

Responsibilities

• Evaluate processes and equipment to meet quality requirements.
• Develop quality plans for equipment and processes.
• Monitor process performance to standards and apply ISO/QSR rules.
• Collaborate with manufacturing, sourcing, and development teams.
• Develop and maintain department and project budgets.

Skills

Team collaboration

Quality engineering

Communication

Statistical analysis

Blueprint reading

GD&T / CMMs

Education

B.S. in Engineering

CQE or CRE certification

Tools

Microsoft Office

Optical comparators

CMMs

Job description

Zimmer is seeking a Quality Engineer to ensure medical device quality from design through production. You will apply ISO/QSR standards, lead quality improvement projects, and collaborate with cross-functional teams to resolve issues and implement robust processes.

Ideal candidates hold a BS in engineering with a CQE/CRE, 5–7 years in quality engineering, and proven ability to drive deadlines and budgets while maintaining strong supplier relations.