Summary:Manages the development and implementation of the organization's quality policies and programs.
Manages and mentors Quality Department staff (Quality Assurance, Quality Control, Quality Engineering and/or Quality Compliance).
Assures systems are in compliance with ISO and FDA quality system regulations.
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, Marketing, Legal, Finance, 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., GMP, ISO).
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 activitiesDefines and specifies the implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy, and reliability of company productsParticipates in the reviewing of engineering designs to contribute quality requirements and considerationsAssists product support areas in gathering and analyzing dataSelects, develops, and evaluates personnel to ensure the efficient operation of the functionStrong tactical decision-maker handles unforeseen issues as they relate to organization's compliance with regulationsRegularly interacts with different levels of the organization on matters regarding organization's compliance with regulationsExercises supervision in terms of costs, methods, and staffingUnderstand domestic and international Quality System Requirements and how they interact to provide quality guidance to other departments and companiesEstablishes 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 solutionsDevelop and deliver the requirements for the Dexcom Quality Engineering organizationSupports complex, cross-functional quality issues in a variety of subject matter areas and drivesresolution and proactive solutions to customer complaintsActively 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 goalsReviews data on product defects, product response plans, and product dispositions; recommends and implements improvementsTakes 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 costsWorks and communicates effectively and professionally in a team environment with minimal supervisionApplies proficient computer skills in Microsoft Office and database applicationsThis job description reflects management's assignment of essential functions; it does not prescribe or restrict the tasks that may be assignedAssumes and performs other duties as assignedRequired Qualifications: Bachelor of Science or Engineering degree with minimum 9 years of related industry experience and training; or equivalent combination of education and experience.
Preferred Qualifications: Medical device or regulated industry experienceKnowledge and understanding of the Food and Drug Administration (FDA) 21 CFR and International Organization for Standardization (ISO Quality management systems)Management experience or leadTechnical writing skills as applied to manufacturing documentation and process development - Experienced in creating and revising technical documentationHands-on experience with high-volume manufacturing and equipment development for assembly and automation systemsSupervisory Responsibilities:Directly supervises employees.
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
Is responsible for the overall direction, coordination, and evaluation of this areaResponsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.Language Skills:Must be able to communicate effectively in English.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and correspondence.
Ability to speak effectively before groups of customers or employees of organization.