QA Inspector 2

Dexcom; George Town; On-site; MYR 60,000 - 90,000; Full time

Benefits offered by this job

Comprehensive benefits program

Career development programs

Global growth opportunities

Tuition reimbursement

Job summary

Dexcom Corporation, a global leader in continuous glucose monitoring, seeks a QA inspector for the Lot Release team in Penang. The role ensures final product documentation meets GDP/cGMP standards and conducts in-process inspections to verify product quality and regulatory compliance.

The ideal candidate has experience in QA/QC within medical devices or manufacturing, with a track record of adhering to procedures and contributing to corrective actions.

Qualifications

• Performs final product reviews of manufacturing and quality documentation to ensure GDP and cGMP compliance.
• Conducts in-process inspections and testing to verify products meet specifications and regulatory standards.
• Follows approved procedures, work instructions, and training requirements, completing training before duties.
• Initiates, documents, and assists with Non-Conformance investigations with data gathering and CAPA support.
• Monitors equipment and work areas to ensure cleanliness, maintenance and safety aligned with quality requirements.
• Supports continuous improvement initiatives to enhance quality processes and efficiency.
• Performs other duties as needed to support departmental objectives.

Responsibilities

• You will perform final product reviews of manufacturing and quality documentation to ensure accuracy, signature, dates, and GDP/cGMP compliance.
• You will conduct in-process inspections and testing to verify products meet established specifications and regulatory standards.
• You will ensure all tasks are performed per approved procedures and training requirements, completing needed training before performing responsibilities.
• You will initiate, document, and assist with Non-Conformance investigations by identifying quality issues and gathering information.
• You will monitor equipment, instruments, and work areas to ensure cleanliness, maintenance, and safe operation.
• You will support continuous improvement initiatives to enhance quality processes and operational efficiency.
• You will perform other duties and responsibilities as assigned to support departmental objectives.

Skills

Final product reviews

In-process inspections

GDP compliance

cGMP

NC investigations

Training compliance

Cloud PLM

Oracle

Camstar

Tools

Cloud PLM

Oracle

Camstar

Job description

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.

Meet The Team

As a member of the QA Lot Release team, the inspector is responsible for ensuring the activities related to the inspection functions in a manner which meets company standards and methods as determined by quality assurance or other engineering departments.

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.

Where You Come In

• You will perform final product reviews of manufacturing and quality documentation to ensure accuracy, completeness, proper signatures, correct dates, and compliance with Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP).
• You will conduct in-process inspections and testing to verify that commercial products meet established specifications, quality requirements, and regulatory standards.
• You will ensure all assigned tasks are performed in accordance with approved procedures, work instructions, and training requirements, and you will complete all required training before independently performing job responsibilities.
• You will initiate, document, and assist with Non-Conformance (NC) investigations by identifying quality issues, gathering relevant information, and supporting corrective and preventive actions.
• You will monitor equipment, instruments, and work areas to ensure they are clean, properly maintained, and safe for use in accordance with quality and safety requirements.
• You will support continuous improvement initiatives by identifying opportunities to enhance quality processes, documentation practices, compliance activities, and operational efficiency.
• You will perform other duties and responsibilities as assigned to support departmental objectives and business needs.

What Makes You Successful

• You demonstrate good interpersonal and teamwork skills.
• You must be able to flex your schedule to work different shifts to meet demand.
• You have experience in Quality Assurance and/or QA/QC.
• You have at least 2 years of experience in the medical device or manufacturing industry.
• You ideally have experience working with Cloud PLM, Oracle, and/or Camstar software programs.

What You\’ll Get

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

AI in Hiring Notice

We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.

At Dexcom, we are committed to providing a fair and inclusive recruitment process, and welcome candidates of all genders and gender identities to apply. If any wording in this description appears unintentionally gendered or exclusionary, please be assured this is not intentional.

Should a reasonable accommodation be necessary to aid a disability, requests should be sent to Dexcom Talent Acquisition at [e-mail].