Amgen Jobshttp://www.amgen.jobs2012-05-27 00:54:57.089083USAThousand OaksAuto req 14257BR Job Posting Title Director, Quality Engineering- Drug Delivery Career Category Quality Employee Subgroup Salaried FT Country (State/Region) United States - California Location (City) Thousand Oaks Amgen Job Description The successful Director of Device Quality Engineering will lead and build a dynamic team that supports all new product development across the organization. In this high profile assignment you will lead a team of direct reports (Quality Engineers) responsible for design assurance for new and existing technology. This team is responsible for accurate, independent evaluation of Design History File documentation, Design intent and Design Quality. A key driver of success in this role is to translate design requirements into processes that ensure quality attributes in the design are maintained and are practical for manufacturing. You also will be the Device Quality Project lead on various high profile combination product teams. The candidate will work closely with Device Engineering to facilitate the development of innovative technology in a timely manner. Programs are focused on early development through transition to manufacturing with some sustaining work and will include risk management, reliability and failure analysis, and quality planning. Other responsibilities include independently determining appropriate test, verification and validation parameters to ensure components and products meet specifications requirements. The incumbent should have an understanding of drug product and drug product development requirements. Key Responsibilities: • Plans, conducts and executes design control activities requiring judgment in the independent evaluation, selection and the substantial adaptation of best practice engineering techniques, testing procedures and criteria. • Ensure team works closely with product development engineering and the supplier/contractor team to establish the system design specifications and product requirements. • Ensure team works closely with design, development, quality, regulatory, and the supplier/contractor team to establish and document the master verification and validation plans in conformance with the system design specification and sound testing principles. • Assists in the planning, coordinating and execution of design verification and validation testing to directly support the master verification and validation plans, including any additional activities such as HALT/HASS and IEC 60601-1-x testing, HFE studies, clinical trials and other standardized test methods. • Participates with the engineering team to establish and drive the design FMEA, FMECA and other risk related activities (ISO14971). • Facilitate the achievement of business goals for device reliability, quality, customer satisfaction, cost and safety by identification, development, and accomplishment of key initiatives supporting the business objectives and operational goals for device quality improvements, customer satisfaction, supplier and component initiatives, and safety. • Product reliability design improvements by ongoing research, design and further development of existing products to continuously improve device reliability, quality, and customer satisfaction. Validated product changes with completed documentation that meets or exceeds established guidelines, plus well-documented research/analyses that support decisions and conclusions. • Validation of supplier processes and support of supplier/contractor Quality Agreements. Basic Qualifications • Doctorate degree & 4 years of directly related experience OR • Master’s degree & 8 years of directly related years OR • Bachelor’s degree & 10 years of directly related experience AND • 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications • Advanced degree in an Engineering discipline, or other Engineering/Life Sciences related discipline and 10 years of business experience, leading development organizations in multiple parallel and virtual development environments. • 4 years of Quality managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources and have lead the commercial launch of a medical device. • CQA, CQM, Six Sigma Black Belt preferred. • ASQ Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or Certified Auditor credentials (e.g., ISO 13485). • Lean and or Six Sigma Certification. • Previous experience in Quality engineering and commercialization process with drug delivery devices and combination drug/device products is desired • Design assurance experience in the design and manufacturing scale-up of injectable devices (e.g. auto-injectors, pens, needle-free injectors, syringes) or devices for non-invasive or minimally invasive drug delivery systems (e.g. pulmonary, transdermal). • Familiar with PCB/PCA assembly and fabrication. • Strong background with requirements management, configurations management, defect tracking, and requirements tracing tools • Advanced problem-solving, risk assessment, statistical analysis, and negotiation skills expected. • Experience with complex, cross-functional development projects. • Experience working with and leading cross-cultural teams. • Proven ability to apply situational leadership concepts across various intra and inter-departmental matters. • Demonstrated time management, decision making, presentation and organization skills. • Ability to converse technically with mechanical, electronic, software, clinical, regulatory, and quality engineering disciplines.2012-05-09 20:34:27United StatesAmgenCalifornia14257BRCAThousand Oaks, CA28581281http://www.amgen.jobs/xml/28581281/job