• 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 • Safety/Environmental: -Where applicable, individual is pre-planning safety into work activities to improve performance -Proactively identifies safety concerns -Complies with Environmental Management System program SOP’s/WI, Policy & Program elements and encourages responsible use of resources • Actively participate in continual improvement/innovation, corrective action and internal/external customer satisfaction
Qualifications - Education & Experience
• Bachelor degree in an engineering discipline or equivalent experience, per engineering criteria matrix • Minimum six (6) years quality/regulatory experience • 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
With over five decades of experience, Phillips-Medisize is a global-leader of outsource design, development and manufacturing services, delivering innovative and complete end-to-end capabilities to our customers. Our foundation is built on the core principles – quality, innovation and investment – which have led us to our current industry leadership position.Phillips-Medisize's mission is to ensur...e you, our customer, receive the highest level of satisfaction using our state-of-the-art technology, innovative design, creative people and appropriate facilities. Our facilities, totaling over 2 million square feet, adhere to the most rigorous global requirements while providing a quality system adaptable to local standards. The heart and soul of Phillips-Medisize is our people. Their expertise and knowledge allow us to rise to your challenge. As we partner with you through every step of the process, we are able to carefully design and build a product to meet your needs, often resulting in shortened time-to-market and reduced overall program cost.