QA Engineering Manager

Summary: 

Are you looking to leverage your experience to be part of something big and help people take control of their health? Do you enjoy building and managing relationships to better understand the needs of the business, and then creating and implementing solutions to meet those needs? Do you want to be part of a high-performing team dedicated to doing the right thing? If so, then we have an opening for you!    

Come join our Engineering Team at our Manufacturing Site in Athenry as a Quality Assurance Engineering Manager. 

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 (performance expectations vary by level): 

• 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 

• Responsible for ensuring the Quality Management System requirements are established and maintained at site and the internal policies, customer expectations, and regulatory requirements are met 

• Develop and deliver the requirements for the Dexcom Quality Engineering organization 

• Change Leader driving a culture of continuous improvement by employing Practical Process Improvement concepts and managing metrics, tier system escalations, reporting and communicating internally 

• 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. Know techniques like six sigma, lean manufacturing, sampling plans, and another statistical modeling 

• 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 (such as Oracle, Agile, and MiniTab) 

• 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.  

Qualifications:   

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily per defined job level. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  

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 820 and International Organization for Standardization (ISO 13485 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. 

‘It’s so lonely ‘round the fields of Athenry’ - Come join us, apply now!