Summary:Position may be responsible for various aspects of Quality Engineering, including supervision of support personnel and/or administration of specific aspects of the quality system. Job tasks require interfacing with all functions (Operations, Quality Assurance, Engineering, Regulatory Affairs, Clinical Affairs, Biometrics, Marketing, Legal, Finance, Sales, Customer Operations, Human Resources and upper levels of management). Personnel in this role must be systematic, highly organized and articulate and work in a team environment. Provides technical support for the projects, functions, and strategic objectives of quality. Responsible for planning, implementing, and managing compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for worldwide distribution.
Designs methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment, and finished products. Assure compliance to in-house and external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma). Provide guidance on NCMR dispositions and investigations and guidance on the CAPAs.
Essential Duties and Responsibilities:Develops, implements, and maintains technical quality assurance and control systems and activities.
Defines and specifies the implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy, and reliability of company products.
Participates in the reviewing of engineering designs to contribute quality requirements and considerations.
Assists product support areas in gathering and analyzing data.
Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
Strong tactical decision-maker handles unforeseen issues as they relate to organization's compliance with regulations.
Regularly interacts with different levels of the organization on matters regarding organization's compliance with regulations.
Supervise team in terms of costs, methods, and staffing.
Understand domestic and international Quality System Requirements and how they interact to provide quality guidance to other departments and companies.
Establishes operational objectives and work plans for the Quality Department and delegates assignments to subordinates. Specifically, assuring subordinates are meeting sustaining project deliverables, creating communication between cross-functional departments, participating in the process or product investigations, identifying potential root causes, and providing business solutions.
Develop and deliver the requirements for the Dexcom Quality Engineering organization.
Supports complex, cross-functional quality issues in a variety of subject matter areas and drives resolution and proactive solutions to customer complaints.
Actively participate as a core team member of sustaining management team (Process Engineering, Operations, and Quality Assurance).
Responsibilities include providing technical guidance determining failure mode effects and analysis (FMEA).
Utilizes quality feedback data from customers and consumers to drive continual improvement activities needed to achieve department strategic goals.
Reviews data on product defects, product response plans, and product dispositions; recommends and implements improvements.
Takes the initiative to develop systems and processes that:improve product safety;
increase product consistency and conformance to requirements;
improve production efficiency;
reduce operating and scrap costs.Works and communicates effectively and professionally in a team environment with minimal supervision.
Applies proficient computer skills in Microsoft Office and database applications.
This job description reflects management's assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned.
Assumes and performs other duties as assigned.
Required Qualifications:Bachelor of Science or Engineering degree with minimum 7 years of related industry experience and training; or equivalent combination of education and experience.
Preferred Qualifications:Medical device or regulated industry experience.
Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR and International Organization for Standardization (ISO Quality management systems).
Management experience or lead.
Technical writing skills as applied to manufacturing documentation and process development - Experienced in creating and revising technical documentation.
Hands-on experience with high-volume manufacturing and equipment development for assembly and automation systems.#J-18808-Ljbffr