Dei BioPharma Ltd
Announcement Number: DB/05/2025/MDO3
Position Title: QA Officer – Medical Diagnostic Devices (Number of positions: 02)
Opening Period: 05/05/2025 – 05/12/2025
Series/Grade: L (4)
Salary: Competitive
Who May Apply: All Interested Applicants
Duration Appointment: Indefinite, subject to successful completion of probationary period
Supervisory Position: None
Job Summary:
The Quality Assurance Officer – Medical Diagnostic Devices is responsible for ensuring that all manufacturing activities, processes, and products related to in vitro diagnostic (IVD) devices comply with applicable quality standards including ISO 13485, GMP, and national/international regulatory requirements. The officer will review batch records, monitor in-process controls, handle non-conformities, support validations and ensure documentation accuracy across production and quality systems.
This role will also support internal audits, CAPA processes and regulatory inspections to ensure product safety, performance, and regulatory compliance. The ideal candidate must be experienced in quality assurance within a medical device or diagnostics environment and demonstrate a proactive approach to risk management and quality systems enforcement.
Key Duties and Responsibilities:
1. Review and approve batch records, quality control results and documentation related to medical diagnostic device production.
2. Ensure compliance with ISO 13485, CGMP, and local regulatory guidelines during manufacturing and quality control processes.
3. Perform in-process checks, environmental monitoring verification and line clearance validations in production zones.
4. Investigate and document non-conformances, deviations and product complaints; initiate and monitor CAPAs.
5. Participate in validation of new products, processes, and equipment including IQ/OQ/PQ activities.
6. Coordinate document control activities including SOPs, BMRs, logs and quality forms related to diagnostics.
7. Conduct internal audits and assist with supplier audits and regulatory inspections.
8. Support product release processes by reviewing Certificates of Analysis (CoAs), QC data and inspection reports.
9. Promote adherence to Good Documentation Practices (GDP) and data integrity (ALCOA+) principles.
10. Train production and quality staff on quality procedures, hygiene standards, and regulatory expectations.
Academic Qualifications:
Bachelor’s degree in Biomedical Engineering, Medical Laboratory Technology, Industrial Chemistry, Quality Assurance, or a related scientific field. Certification in ISO 13485 or internal auditing is an added advantage.
Experience and Competencies:
1. Minimum of 3-5 years’ experience in quality assurance for medical devices, diagnostics or pharmaceutical manufacturing.
2. Sound knowledge of ISO 13485, GMP, GDP, and regulatory frameworks for IVDs.
3. Hands-on experience in audit preparation, CAPA management, and QA documentation control.
4. Familiarity with cleanroom classification, aseptic processing and device batch record review.
5. Strong interpersonal, organizational and analytical skills.
6. Ability to work collaboratively with cross-functional teams under regulatory pressure.
All applicants under consideration will be required to pass medical and security certifications.
EQUAL OPPORTUNITY EMPLOYER: Dei BioPharma Ltd, provides equal opportunity and fair and equitable treatment in employment to all people without regard to race, color, religion, sex, national origin, age, disability, political affiliation or marital status.
HOW TO APPLY:
All interested candidates who meet the required qualifications and experience are invited to submit their CVs, Cover Letter & Academic documents (addressed to the Human Resources Manager)
All Application documents should be merged as one document in PDF or DOC / DOCX, which should not exceed 10MB
Applications should be sent by email to recruitment@deibiopharma. com with the JOB TITLE IN THE SUBJECT LINE
Should you not hear from us within twenty one (21) days from the closing date of this advertisement, you may consider your application to be unsuccessful
Deadline: 12th May 2025 by 5:00PM
