Job Description

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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.

Performs inspections, checks testing and sampling procedures for product manufacturing processes. Carries out packaging line, manufacturing inspections and sampling and testing of in-process and Lot Release to ensure that company standards are met. Monitors critical equipment and instrumentation. May apply approval or rejection labels to lot/product once analytical data is evaluated.

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 minimal supervision by Lead / Supervisor
• Must have strong organization skills and attention to detail
• Assumes and performs other duties as assigned.

• 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

• 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

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

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