Quality Engineer

Requisition Number: POS2569

Location: Phillips Medical - Menomonie, WI

Responsibilities

• 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

Qualifications - Education & Experience

• 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 (level 45) (see engineering progression levels for meeting higher levels)

Qualifications - Skills & Competencies

• 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