- Location
- Penang,MY, MY
- Type
- Full-time
- Experience
- 2+ years
- Source
- Eightfold
Description
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.
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.
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