Manager QA Engineering

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.

We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

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, 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. Strong tactical decision-maker handles unforeseen issues as they relate to organization's compliance with regulations.
• 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
• 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.
• Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
• Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
• Responsible for reviewing, authoring, and revising appropriate technical documentation including design history file, standard operating procedures, protocols, reports, etc.
• Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations. Some examples include Equipment, Process, Software and Test Method Validation, Auditing, Calibration, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls, Receiving inspection, Training.
• Leads or participates in internal audits, supplier audits to ensure systems comply with requirements and are effective. Supervise team in terms of costs, methods, and staffing.
• Applies risk management, validation, sample size, and external standards review and implementation activities. Assists with investigation and disposition of nonconforming materials with the Materials Review Board.
• Regularly interacts with different levels of the organization on matters regarding organization's compliance with regulations. Actively participate as a core team member of sustaining management team (Process Engineering, Operations, and Quality Assurance).
• Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel and MiniTab).
• May assure compliance to in house and/or external specifications and standards (i.e. GLP, GMP, ISO Six Sigma).
• May supervise and administer specific aspects of the quality system.
• Assumes and performs other duties as assigned.
  
  

Required Qualifications

• Bachelor's degree and minimum of 8 years of related experience; or Master degree with 5 years equivalent industry experience; ; or a PhD with 2 years of related experience; or equivalent combination of education and experience.
• Also required 2-5 years of management experience or lead. At least 3 years of hands-on experience with high-volume manufacturing and equipment development for assembly and automation systems.
• Medical Device experience preferred. Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems).
• Must have strong communication, presentation, organization, planning, and the interpersonal skills necessary to work as a team member and act as a liaison with customers.
• Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel, Power BI, MiniTab/JMP) is preferable.
• Proficiency with statistical tools (Minitab, JMP, or equivalent) and hands-on experience in root cause analysis and corrective actions (8D, DMAIC)
• Deep knowledge of quality methodologies such as FMEA (DFMEA & PFMEA) or MSA & SPC.
  
  

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.