Avalign is looking for a Quality Engineer to join our Warsaw, IN location.
What You Will Do:
Responsible for owning and executing quality system processes in support of quality objectives. The Quality Engineer will utilize a data driven approach to define or improve quality systems, quality processes or overall product quality.
- Facilitate or perform documented customer complaint investigations and complete any required customer responses.
- Quality lead for customer-based planning of new product launches, legacy product maintenance and customer related change control. Typical responsibilities include but are not limited to revising existing or creating; Control Plans, pFMEA, Gage R/R, final product acceptance inspection plans, and performing process capability studies in addition to meeting customer specific deliverables.
- Primary quality representative for site supplier management and resolution of supplier nonconformances.
- Support internal and external audits to maintain regulatory, customer and Avalign procedure compliance.
- Coordinate CAPA and SCAR investigations and closures in compliance with regulatory, customer and Avalign requirements.
- Participate in Material Review Boards. Identify non-conformance trends and develop technical investigation plans.
- Investigate and analyze customer/internal complaints for trends and potential improvements.
- Responsible for the development and execution of qualification and validation protocols. Summarizes results in reports.
- Utilize standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
- Establish and support a work environment of continuous improvement that aligns with Avalign’ s Quality Policy, Quality System, and the appropriate regulations for the areas they support.
What You Won’t Do:
- Feel stuck – we offer great opportunities to advance and learn
- Get bored – we make custom products, so no day is the same
- Feel like a number – we’re a close-knit bunch and always have each other’s backs
Who you are:
- A self-starter who thrives in a fast-paced environment
- A quick learner who is always ready to gain depth of knowledge in manufacturing processes
- A reliable worker who knows the importance of showing up when it counts
- Accept assignments with open, cooperative, positive and team-oriented attitudes
- Able to plan and execute plans across teams
- Effective communicator, both written and verbal
What You Will Need:
- Bachelor’s Degree in engineering
- Three (3) plus years of relevant quality experience
- Experience with Medical Device manufacturing preferred
Avalign conducts a comprehensive background check that includes drug testing
- Pay Type Salary
- Warsaw, IN, USA