Quality Engineer Job Description
The ideal candidate will possess strong analytical skills, a keen eye for detail, and excellent communication abilities. They will work closely with cross-functional teams to ensure seamless equipment qualification processes.
Key Responsibilities:
* Support quality control compliance by ensuring adherence to safety and regulatory standards.
* Document and execute equipment qualification processes from initial assessments to Operational Qualification (OQ).
* Follow established procedures and protocols for new equipment qualification to embed quality practices within workflows.
* Assist in reviewing and completing Test Outlines and Procedures (TOPs) to verify alignment with quality specifications.
* Support the planning and organization of commissioning materials and consumables to meet required quality standards.
* Monitor equipment qualification activities to ensure timely completion while maintaining high quality standards.
* Prepare and maintain Qualification Summary Reports (QSRs) and related documentation to ensure compliance with quality standards.
* Participate in equipment Design Evaluations, Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to achieve quality outcomes.
* Manage quality control processes related to equipment qualifications, including documentation control, change controls, and punch list tracking.
* Collaborate with project contractors and equipment vendors to perform and verify tests, upholding quality control.
* Provide support for quality assurance tasks throughout the equipment qualification process, ensuring consistent quality standards.
Requirements
* BS or MS in a relevant science or engineering field, or equivalent experience.
* 2+ years of industry-related experience in a similar role.
* Strong oral and written communication skills, with a focus on clear documentation and reporting.
* Strong problem-solving skills with a focus on Quality Control.
* Customer-service oriented and able to collaborate well with internal teams and external vendors.
* Familiarity with life science manufacturing processes such as biotech, aseptic fill/finish, oral solid dose (OSD), and gene therapy, or equivalent experience.
* Willing and able to travel domestically and internationally, if required.
Benefits
* Pension Fund
* Medical Aid / Health Care
* Dental Care
* Income Protection
* Group Life Assurance