Staff QA Engineer

1 week ago

George Town, Penang, Malaysia Dexcom Inc. 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:

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. A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.

Essential Duties and Responsibilities:

  • Design, implement and maintain quality assurance protocols and methods for processing materials into partially finished or finished products.
  • 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.
  • 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.
  • Design methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
  • Perform 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.
  • 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.
  • Design and apply company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations.
  • Lead or participate in internal audits, supplier audits to ensure systems comply with requirements and are effective.
  • Participate as a member of the design team, assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.
  • Design and perform Equipment, Process, Software and Test Method Validations.
  • Provide technical guidance with respect to equipment, software, product, and process requirements including defining and identifying failure mode effects and analysis (FMEA).
  • Apply risk management, validation, sample size, and external standards review and implementation activities.
  • Assist with investigation and disposition of nonconforming materials with the Materials Review Board.
  • Read, write, and understand specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
  • Review schematics and mechanical drawings.
  • Apply proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel and MiniTab).
  • Assume and perform other duties as assigned.

Supervisory Responsibilities:

This position may manage a small group of individuals (Technicians and Inspectors). Administer supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Education and/or Experience:

Bachelor's degree and minimum 7 years of related experience; or a Master's degree with minimum 5 years of related experience; or a PhD with 2 years of related experience; or equivalent combination of education and experience. Medical Device experience preferred.

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