Quality Engineer

Warsaw, IN, USA Req #210
Monday, July 26, 2021
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer’s quality specifications for each product we produce.

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

What You’ll Enjoy:

  • Competitive wage and benefits package
  • Employee bonus program
  • Medical, dental, and vision insurance
  • Vacation and paid holidays
  • Life and AD&D insurance, disability insurance
  • Tuition reimbursement
  • Great 401k with company match
  • Employee referral program
  • Temperature controlled environment
  • Community involvement investing and giving back to the community
  • Additional free resources such as travel assistance, EAP, etc.

 Avalign conducts a comprehensive background check that includes drug testing
 

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status.

Other details

  • Pay Type Salary
  • Warsaw, IN, USA