Quality Engineer

Requisition Number: P9477

Location: Phillips Medical - Menomonie, WI

Coordinate new process techniques that improve overall job efficiencies
Implement systems and procedures compliant with ISO 13485, 21CFR820, 21CFR Part 210 and 211
Be a technical resource for the initiation and implementation of cost improvement plans on new and existing programs
Development and implementation of statistical incoming and in-process sampling/control plans
Manage the qualification of processes performed by PPC suppliers; troubleshoot and lead corrective actions relating to supplier performance; improve process for supplier data submission to reduce internal inspections
Participate in AQP meetings representing quality, where appropriate
Provide engineering team with information and analysis tools as needed
Facilitate communication between engineering function, manufacturing, and quality
Responsible for being a communication liaison between the customer and manufacturing facility
Lead development and review of validation plans and protocols
Measure validation process effectiveness and lead continual improvement of system
Communicate and coordinate activities including internal and external approvals of validations

B.S. degree in engineering, statistics, chemistry or biology with 0-2 years of related experience, or,
4-6 years directly related experience and education with no degree for minimum requirements

Understanding of the project development process, associated terminology, and quality system requirements
Ability to effectively present information and respond to questions from group of managers, sales, and customers
Strong communication (verbal and written), teamwork and organizational skills
Ability to identify problems, and develop and implement actions to resolve them
Ability to motivate and influence people to achieve customer satisfaction
Demonstrable track record of project accomplishment
Demonstrable track record of planning activities with contingency actions

Medical