Job Summary:

The Quality Engineer III develops, establishes and maintains quality engineering methodologies, systems, and practices which meet internal, customer, and regulatory requirements. They serve as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. They provide focused quality engineering support within new product development, operational, or system/services support. Functional Engineering Roles include Design Assurance, Operations Quality, Software Engineering, Supplier Assurance, Product Analysis, Metrology, Microbiologist, Chemist.

Responsibilities:

Provides leadership role on championing departmental or cross-functional engineering initiatives.

Provides project direction, coaching, and mentoring for engineering and technical team personnel.

Proactively investigates, identifies , and implements best-in-class Quality Engineering practices.

Mentor for technical guidance for identifying and resolving quality issues.

Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.

Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.

Applies sound, systematic problem-solving methodologies in identifying , prioritizing, communicating, and resolving quality issues.

Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.

Quality Systems Duties and Responsibilities:

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Qualifications:

5 - 7 Years with BS, 3 - 6 Years with MS

Medical Device experience

Analytical thinker

Attention to detail

More experienced in technical writing

Other Details:

Schedule: 08:00 AM - 04:30 PM (Flexible)

Work Setup: Onsite in Spencer, IN

Contract Length: 12 Months

Start Date: 8/25/2025

Requirements Implementing assurances, process control systems, and CAPA systems Quality engineering experience within new product development, operational, or system/services support Experienced in technical writing