
Senior Quality Engineer
- Round Lake, IL
- $88,000-121,000 per year
- Permanent
- Full-time
- Utilizes DMAIC tools to investigate non-conformances and participates in (CAPA)-related activities, including CAPA ownership.
- Utilizes engineering product development/process knowledge to solve straight forward problems. (e.g., FMEA, Design of Experiments, Molding, etc.)
- Performs standard engineering assignments to support change controls and assists cross-functional teams in identification of risks. Supports product testing to ensure product conformance to specifications.
- Understands principles of complaint handling process and supports complaint investigations.
- Conducts complaint trend analysis and analyzes data from various sources (Non-Conformances, Field Corrective Actions, and Complaints) to drive decisions. Facilitates small project teams as needed to accomplish team objectives. Supports Quality internal and external audits as required.
- Provides support for New Product Development and guides team through the development process to ensure compliance to quality systems.
- Three or more years of engineering experience with a bachelor’s degree in engineering required.
- Prior experience in product development, design and/or testing within medical device industry.
- Experience with electromechanical devices preferred.
- Display basic understanding of Quality Management System and GMP.
- Display a technical understanding of engineering and product development principles and procedures.
- Possess basic understanding of statistical process controls (SPC), measurement systems analysis (MSA), and DMAIC investigation tools.
- Familiarity with Minitab preferred. Display basic understanding of change controls and risk management principles.
- Experience in working with cross-functional teams, including technical and non-technical work.
- Ability to prioritize and present technical information with minimal assistance.
- Demonstrates proven organizational skills and ability to work independently.