QA Inspector 3

3 days ago

Simpang Ampat, Malaysia Dexcom Full time

**Summary**:
As a member of the QA Lot Release team, the inspector is responsible to ensure 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.

**Essential Duties and Responsibilities**:

- Performing in-process and final product review of documents for accurate format, signatures, dating and Good Documentation Practices (GMP) for commercial product in a timely matter
- Maintain compliance with operating procedures and ensure training is completed prior to the operation of a task
- Ensure all documentation is legible, complete, and correct per current Good Manufacturing Practices Inspect labeling for the finished product
- Understand and perform line clearance activities in manufacturing
- Perform in-process quality audits in manufacturing to assure compliance to manufacturing documentation and good documentation practices
- Initiate and assist with the NCMR process during manufacturing of commercial product
- Demonstrate good computer skills and perform computer operations to generate reports and graphs using Microsoft Word and Excel
- Perform in-process product inspection and testing for commercial product
- Must be able to distinguish between certain colors
- Review shipping documentation to assure accurate order shipment
- Provide training for new employees and shadow new hire during probation period
- Takes on new challenges and expanding roles to assist with growing demands within different areas of the Quality Department
- Responsible to support Lead / Supervisor overseen team as assigned
- Able to work independently with mínimal supervision by Lead / Supervisor
- Must have strong organization skills and attention to detail
- Assumes and performs other duties as assigned.

**Required Qualifications**:

- Typically requires a high school certificate (SPM) or Diploma in any field or equivalent with minimum 3 years of relevant industry experience and/or training
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required
- Experience using computer
- Ability to understand and perform job per documents instructions in English
- Good interpersonal and teamwork skills
- Must be able to flex schedule to work in different shifts to meet demand

**Preferred Qualifications**:

- Quality Assurance and/or QA/QC experience
- Min 3 years in the medical device industry or manufacturing industry previous experience
- Ideally has experience working with the following: Cloud PLM, Oracle and/or Camstar software programs
- Able to communicate fluently in English is preferable

**Education Requirements**:

- High school certificate (SPM) or Diploma in any field or equivalent

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