QA Inspector 2

21 DexCom Malaysia Sdn Bhd; Penang; On-site; MYR 60,000 - 80,000; Full time

Job summary

Dexcom Malaysia Sdn Bhd is seeking a QA Lot Release inspector to join the team responsible for ensuring product documentation accuracy and regulatory compliance in a CGM manufacturing environment.

The role involves in-process inspections, strict adherence to GDP and cGMP, and collaboration with QA and manufacturing teams to drive quality and efficiency.

Qualifications

• Must have the ability to flex schedule to meet demand.
• Experience in Quality Assurance and/or QA/QC.
• At least 2 years in the medical device or manufacturing industry.
• Experience with Cloud PLM, Oracle and Camstar software is preferred.

Responsibilities

• Perform final product reviews of manufacturing and quality documentation to ensure accuracy, completeness, and GDP/cGMP compliance.
• Conduct in-process inspections and testing to verify products meet specifications and regulatory standards.
• Ensure tasks follow approved procedures and training requirements; complete required training before duties.

Skills

Interpersonal skills

Teamwork

Flexible schedule

QA/QC experience

Medical device experience

Tools

Cloud PLM

Oracle

Camstar

Job description

Company Overview

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.

Role Overview

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.

Responsibilities

• 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.

Benefits

• 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.

Company Culture

Since 1999, Dexcom has simplified and revolutionized diabetes management, positively impacting millions worldwide. At Dexcom, we’re more than just a medical device company; we’re a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.

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].

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.