Sr Manager QA Engineering

3 days ago

George Town, Penang, Malaysia Dexcom Full time
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

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
  1. Develops, implements, and maintains technical quality assurance and control systems and activities.
  2. Defines and specifies the implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy, and reliability of company products.
  3. Participates in the reviewing of engineering designs to contribute quality requirements and considerations.
  4. Assists product support areas in gathering and analyzing data.
  5. Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
  6. Strong tactical decision-maker handles unforeseen issues as they relate to organization's compliance with regulations.
  7. Regularly interacts with different levels of the organization on matters regarding organization's compliance with regulations.
  8. Exercises supervision in terms of costs, methods, and staffing.
  9. Understand domestic and international Quality System Requirements and how they interact to provide quality guidance to other departments and companies.
  10. 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.
  11. Develop and deliver the requirements for the Dexcom Quality Engineering organization.
  12. Supports complex, cross-functional quality issues in a variety of subject matter areas and drives resolution and proactive solutions to customer complaints.
  13. Actively participate as a core team member of sustaining management team (Process Engineering, Operations, and Quality Assurance).
  14. Responsibilities include providing technical guidance determining failure mode effects and analysis (FMEA).
  15. Utilizes quality feedback data from customers and consumers to drive continual improvement activities needed to achieve department strategic goals.
  16. Reviews data on product defects, product response plans, and product dispositions; recommends and implements improvements.
  17. 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.
  18. Works and communicates effectively and professionally in a team environment with minimal supervision.
  19. Applies proficient computer skills in Microsoft Office and database applications.
  20. This job description reflects management's assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned.
  21. Assumes and performs other duties as assigned.
Required Qualifications
  1. 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
  1. Medical device or regulated industry experience.
  2. Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems).
  3. Management experience or lead.
  4. Technical writing skills as applied to manufacturing documentation and process development - Experienced in creating and revising technical documentation.
  5. Hands-on experience with high-volume manufacturing and equipment development for assembly and automation systems.
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