Beschreibung
For our client, an international pharmaceutical company located in the Hamburg area, we are looking to hire a Quality Engineer (m/f/d) as soon as possible.
Responsibilities:
- Validate a specified product group across various process stages
- Preparation of full documentation: VP, Study (if necessary), IQ, TMV (if necessary), OQ, PQ, VR
- Ensure quality control from validation planning through integration into the Quality Management System (QMS)
- Collaborate within a defined team to execute all relevant validation activities following Standard Operating Procedures (SOPs)
- Identify and implement improvement measures and solutions
- Conduct test method validation and equipment qualification
- Specify and qualify testing instruments and tools
Requirements:
- Proven experience in a regulated, high-volume industrial production environment
- Familiarity with ISO 13485, ISO 9001, FDA regulations, and medical technology standards
We look forward to receiving your application!
Responsibilities:
- Validate a specified product group across various process stages
- Preparation of full documentation: VP, Study (if necessary), IQ, TMV (if necessary), OQ, PQ, VR
- Ensure quality control from validation planning through integration into the Quality Management System (QMS)
- Collaborate within a defined team to execute all relevant validation activities following Standard Operating Procedures (SOPs)
- Identify and implement improvement measures and solutions
- Conduct test method validation and equipment qualification
- Specify and qualify testing instruments and tools
Requirements:
- Proven experience in a regulated, high-volume industrial production environment
- Familiarity with ISO 13485, ISO 9001, FDA regulations, and medical technology standards
We look forward to receiving your application!