Address
Form of workOverview
Reporting to the Director of Quality, the Quality Engineer I will work along the other Quality Engineers towars the maintenance of the QMS. The individual should be able to handle multiple tasks and interact daily with different departments in the company such as Engineering, Manufacturing, Purchasing, and Quality Control. S/he will also provide support related to quality processes within the organization and will assist with the implementation of the ISO 9001 Standard. Some responsibilities for the position will include quality documentation administration, manufacturing data review, customer complaints, and CAPA system administration. We are seeking an individual with a bachelor's degree in mechanical/industrial engineering or similar, with experience in manufacturing, QC, ISO 9001, key metrics and use of Quality tools. The potential candidate must have outstanding communication skills (written and oral), problem solving thinking, as well as excellent interpersonal skills.
Responsibilities
Quality Management System
• Assist mentors with the implementation of ISO 9001.
• Carry out CAPA system follow up, closure, and update.
• Identify opportunities for improvement (OFI) during quality inspection rounds in the manufacturing floor and track the OFIs in the CAPA system.
• Work with service department and QC for the follow up of customer complaints and RMA processes.
• Assist with quality improvement efforts within various departments when needed.
• Assist on writing and reviewing documents.
• Create and track metrics and perform reports on quality according to the department's needs.
• Complete and Review customer questionnaires.
Documentation Control and Quality Records Control
• Keep documentation control log and records control log updated.
• Keep external documentation updated.
• Review records on the production floor (Work Orders, Records, and actual data such as measurements, etc.) and verify them for completion and accuracy.
• Verify data in quality inspection records and check for completion and consistency with manufacturing records.
• Request corrections when needed.
Qualifications
Education /Knowledge:
Work Experience:
Competences
Reporting to the Director of Quality, the Quality Engineer I will work along the other Quality Engineers towars the maintenance of the QMS. The individual should be able to handle multiple tasks and interact daily with different departments in the company such as Engineering, Manufacturing, Purchasing, and Quality Control. S/he will also provide support related to quality processes within the organization and will assist with the implementation of the ISO 9001 Standard. Some responsibilities for the position will include quality documentation administration, manufacturing data review, customer complaints, and CAPA system administration. We are seeking an individual with a bachelor's degree in mechanical/industrial engineering or similar, with experience in manufacturing, QC, ISO 9001, key metrics and use of Quality tools. The potential candidate must have outstanding communication skills (written and oral), problem solving thinking, as well as excellent interpersonal skills.
Responsibilities
Quality Management System
• Assist mentors with the implementation of ISO 9001.
• Carry out CAPA system follow up, closure, and update.
• Identify opportunities for improvement (OFI) during quality inspection rounds in the manufacturing floor and track the OFIs in the CAPA system.
• Work with service department and QC for the follow up of customer complaints and RMA processes.
• Assist with quality improvement efforts within various departments when needed.
• Assist on writing and reviewing documents.
• Create and track metrics and perform reports on quality according to the department's needs.
• Complete and Review customer questionnaires.
Documentation Control and Quality Records Control
• Keep documentation control log and records control log updated.
• Keep external documentation updated.
• Review records on the production floor (Work Orders, Records, and actual data such as measurements, etc.) and verify them for completion and accuracy.
• Verify data in quality inspection records and check for completion and consistency with manufacturing records.
• Request corrections when needed.
Qualifications
Education /Knowledge:
- Bachelor's degree in Industrial/Mechanical Engineering or similar (Required)
- Master's degree in Science/Quality or Statistics (Preferred)
- Manufacturing process of Core and Pathlength products (Required)
- Quality management systems ISO 9001. ISO standards, procedure and process approach, documentation in general (Required)
- CoA, SDS concept and purpose (Preferred)
- Non-conforming control and segregation concepts (Required)
- Quality systems. Tools for improvements. Metrics, objectives, reporting (Preferred)
- Audit procedure, CAPA process, concepts. NC database procedure. Procedure of control of documents and records control (Required)
- Customer Complaints / RMA
Work Experience:
- Quality systems. Tools for improvements. Metrics, objectives, reporting (Preferred)
- CAPA process, concepts. NC database procedure. Procedure of control of documents and records control (Required)
- 2 years in a manufacturing environment (Preferred)
- 2 years or more in Quality (QMS, QA, or QC) (Required)
- 1 year control of documents system (Preferred)
- 1 year of ISO standards implementation, process approach, documentation in general (Required)
- Process measurement (Preferred)
Competences
- Communication and writing skills, comprehension and summarizing skills (Required)
- Computer skills: Word, Excel, Power Point, Web search (Required)
- Unbiased, perceptive, meticulous (Required)
- Process mapping and identification of potential issues (Preferred)
- Analytical, process comprehensive (Required)
- Meticulous, thorough, organized, neat, methodic (Required)
- Teamwork-oriented, cooperative (Required)
