We are currently seeking a Quality Engineer that will be responsible for QE support of operations to ensure quality and operational goals are met. The Quality Engineer will utilize an engineering approach to improve manufacturing efficiencies and the quality of all products while reducing manufacturing costs.
- Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability.
Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
May develop mathematical models to identify units, batches or processes posing excessive failure risks.
Utilize standard statistical analysis and problem solving techniques to determine product acceptance and evaluate process capabilities.
Conducts or guides testing and data analysis which demonstrate that new processes meet acceptance criteria.
Quality lead for customer-based advance planning of new product launches, legacy product maintenance and customer related change control.
Primary quality representative for site supplier management and resolution of supplier nonconformances.
Support internal and external audits to maintain regulatory, customer and Avalign compliance.
Coordinate Complaint, 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.
Responsible for the development and execution of qualification and validation protocols. Summarizes results in reports.
Establish and support a work environment of continuous improvement that supports Avalign’s Quality Policy, Quality System, and the appropriate regulations for the areas they support. Ensure employees are trained to do their work and their training is documented.
B.S. Degree in Engineering or Science in addition to 3 plus years of relevant quality experience.
ASQ Certification (CQE, CRE, Etc.) is considered a plus.
Experience with Medical Device manufacturing is a plus.