Senior Quality Engineer - Akron, United States - Avalign Technologies

Description

We are looking for Senior Quality Engineer at our facility in Akron, OH. The Quality Engineer is responsible for supporting the organization to ensure quality and production goals are met.

The Quality Engineer will utilize an engineering approach to improve manufacturing efficiencies and ensure quality standards of all products are met.

What You'll Do:
Serves as a quality representative to assigned manufacturing areas and/or customers.

Responsible for ensuring compliance with Avalign procedures; customer requirements; and industry regulations, including FDA Quality System Regulation and ISO 13485.

Supports operations and engineering teams to ensure the Material Review Board process is followed.
Provides ongoing quality engineering support to operations, including risk management, developing appropriate inspection requirements; and complaint/NC/CAPA investigations.
Submit documentation to customers for new product launches and legacy product documentation requests.
Manages Non-Conforming Material Reports system and dispositions all non-conforming product.
Enhances and drives product risk management activities. Ensures identified activities and mitigations are executed.
Participates in technical discussions and risk-based decision making.
Identifies opportunities and recommends improvements to quality system and manufacturing processes; drives continuous improvement.
Establish effective corrective action plans.

Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

Recommends test methods and statistical process control procedures for achieving required levels of product reliability.

Conducts or guides testing and data analysis which demonstrate that new processes meet acceptance criteria, including capability studies and Gage R&R studies.

Acts as main Quality Engineering contact for assigned customers and projects.
May supervise quality technicians and/or inspectors as needed at the manufacturing facility.

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'll Need:

Candidates should have a BS in an engineering science plus 3-5 years of manufacturing experience, or an equivalent combination of education and experience.

Ability to read and interpret blueprints as well as have a Knowledge of GD&T, and Inspection methods.
An understanding of quality standards (ISO & regulatory requirements (21CFR820).

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