Job Scope :  Responsible for support of operations to ensure quality and operational goals are met.  The Quality Engineer will utilize an engineering approach to improve manufacturing efficiencies and ensure the quality of all products.

Principal Accountabilities:

• Leads his/her assigned team in the development of quality related processes & initiatives.
• Monitor complaint trends and data in order to escalate emerging issues appropriately.
• Advocates and fosters communication channels with other technical resources internally and with other Avalign manufacturing sites.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• 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.
• Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
• Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures
• Participate in Product Review Boards. Identify non-conformance trends and develop technical investigation plans. Investigates and analyze supplier(S), Customer(s) and Internal complaints and non-conformances.
• Complies with Avalign’s quality system requirements as well as any applicable regulatory requirements.
• Support internal and external audits to maintain compliance.
• Interacts/communicates with external and internal customer(s).
• Complies and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
• Develop & Perform Quality Analysis methods such as (GR&R’s, Capability Studies, Fault Tree Analysis).
• 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 supports Avalign’s Quality Policy, Quality System, and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.

Education and Experience:  College Degree Preferred (preferably in a technical field). 

This position requires 5 plus years of relevant quality experience.  Experience with Medical Device manufacturing is considered a plus. Experience with advance product quality planning as well as problem solving is required. Medical device experience a big plus.