Manager, Design Quality Assurance at Teleflex in Pleasanton, CA
Position Summary The Manager, Design Quality Assurance is responsible for all aspects of Design Quality Assurance Engineering and oversight/management of Quality personnel supporting design control and product development activities. As an integral part of the quality organization team, this position develops, documents, implements, and maintains quality system requirements and procedures related to design, development, and pre-production manufacturing activities. In addition, this position participates and provide quality engineering oversight, management, support, guidance for Neotract functions departments (such as, R&D, Manufacturing/Operations, and Regulatory). This position is responsible for managing a diverse team of quality engineers and technicians that are actively involved in development, verification, validation, manufacturing, and approvals for new products. This position requires adaptability and flexibility in a dynamic, fast-paced environment. As people's manager, s/he leads, supports, mentors and coach's quality engineers and technicians team members as they execute their daily activities. Principal Responsibilities o Supervise, mentor and coach, support, train and develop a highly effective Quality Engineers and Technicians o Manage the activities and performance of Design Quality Assurance Engineers and Technicians supporting design control and all associated product development activities. o Oversee validation of product sterilization processes (including dose map studies) per industry standards. o Oversee product biocompatibility testing of new products per industry standards (ISO10993). o Establish Quality Engineering requirements and inspection/test methodologies for new products across the manufacturing process, including incoming, in-process and final product inspection and monitoring requirements (in conjunction with Manufacturing/Operations) o Provide Quality Engineering oversight and guidance to ensure product development deliverables meet internal and external regulatory requirements, including customer requirements, design specifications, design verifications, design validations, risk management, quality plans and associated deliverables. o Provide Quality Engineering oversight and guidance in conducting risk management activities including, hazard identification, hazard analysis, failure mode effects, and analysis, and risk mitigation. o Oversee the assembly, control, and maintenance of product Design History Files, Device History Records, Risk Management Files, Usability Files, and Technical Files/Design Dossiers. o Evaluate and assess pre-production/manufacturing data to determine the primary factors affecting product quality (including product complaints), yield, throughput, cost, and drive continuous improvement initiative with both internal and external operations as necessary to the point of manufacturing transfer. o Provide technical assistance/guidance and training to the QC function related to inspection methodologies, techniques, processes, and requirements for new products/parts/components. o Assist/support the non-conforming material process and participate in MRB meetings/discussions to address and resolve non-conformances related to products and/or processes. o Oversee the development of quality assurance specifications, inspection & test methods, sampling plans and related written procedures with the objective of driving improve product quality, decrease costs, optimize inspection requirements and increase overall efficiency. o Participate in the creation, review, approval, and disposition of engineer change requests involving product or process changes. o Develop, apply, and promote proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. o Develop, apply, and promote the use of Quality Engineering methodologies, tools, statistical techniques, etc. to assist in the resolution of quality issues during product development. o Promote and maintain effective cross-functional relationships with internal departments such as Operations/Manufacturing, R&D/Engineering, Quality Control, Sales/Marketing, and Regulatory Affairs. Education / Experience Requirements o Bachelor's degree and 10
years of hand-on experience in IS013485, MDR, and FDA QSR compliant Quality Systems in a medical device industry o Minimum of 5 years management experience preferred o Experience with Class II and/or Ill sterile devices (preferred). o Hand-on experience in the use and application of statistical techniques in a product development and manufacturing capacity. o Experience in sterilization validations (radiation) and biocompatibility testing of products
Salary Range:
$150K -- $200K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
years of hand-on experience in IS013485, MDR, and FDA QSR compliant Quality Systems in a medical device industry o Minimum of 5 years management experience preferred o Experience with Class II and/or Ill sterile devices (preferred). o Hand-on experience in the use and application of statistical techniques in a product development and manufacturing capacity. o Experience in sterilization validations (radiation) and biocompatibility testing of products
Salary Range:
$150K -- $200K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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