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Job Description
- Developing and implementing quality standards.
- Developing and implementing quality control documents (IQ,OQ,DQ,FAT,SAT).
- Receive a copy of an un-priced P.O. from procurement department and check that the final product meets P.O. requirements
- Inspect devices throughout the manufacturing process
- Ensuring that workflows, processes,and products comply with safety regulations
- Conduct FAT at pharma star's factory along with the production engineer
- Conduct IQ,OQ,SAT tests at the customer's facility if required
- Preparing a packing list and delivering it with each product as a hard copy to ensure that the client received all the device's components and receiving a signed copy of the list from the client in return.
- Sending the signed packing list to the client via email asking the client to confirm receiving the email
- Inspecting and testing materials, equipment, processes, and products to ensure quality specifications are met.
- Collaborating with production, design departments to develop and implement controls and improvements.
- Investigating and troubleshooting product or production issues.
- Attend weekly development meetings and participate effectively
- Keep record of the QC inspection form for each type of device and present the most common defect in each device in the monthly report
- Maintain department CAPA records and incident reports
- Developing corrective actions, solutions, and improvements.
- Perform root cause analysis and resolve problems
- Undertake continuous training and development
- Keep up with current and developing engineering trends
Job Requirements
- Relevant manufacturing/mechanical engineering bachelor's degree
- Professional accreditation with an industry related body would be advantageous
- 0-1+ years of experience in quality engineering, quality assurance, or a similar role.
- Six Sigma/Lean Manufacturing skills
- Strong communication and interpersonal skills.
- Strong analytical and problem-solving skills.
- Excellent project management skills.
