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Quality Engineer

Requisition Number: P11743

Region: US
State: Wisconsin
City: New Richmond


Work at our newly expanded facility, where we are doing molding and assembly of medical devices/drug delivery systems and kits!  This 7/24 facility offers a fast-paced environment, with a strong, experienced engineering and manufacturing team.

•Be a technical resource for the initiation and implementation of cost improvement plans on new and existing programs
•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
•Coordinate new process techniques that improve overall job efficiencies
•Implement systems and procedures that assure compliance with Quality Standards
•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
•Extended travel to other facilities may be required to support business needs
•Some programs may have vision requirements
•Other duties as assigned

Qualifications - Education & Experience

•Bachelor degree in an engineering discipline or equivalent experience
•Minimum six (6) years quality/regulatory experience (medical manufacturing)
•Minimum Three (3) years auditing experience

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


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