How to become a Quality Assurance Technician in the Medical Devices industry: Complete guide


The position of Quality Assurance Technician is one of the most affordable - and strategic - gateways to the medical device industry. But where to start?

1. Essential training

Although many entry-level vacancies accept different backgrounds, these are the most valued training:

•Technical or Higher Education in the areas of:

•Biomedical engineering

•Pharmacy

•Biotechnology

•Chemistry or Biochemistry

• Production or Industrial Engineering

•Health or Biological Sciences

Knowledge in basic statistics, microbiology, and process validation are also important differentials.

⸻

2. Desired skills and technical knowledge

•ISO 13485 - Quality Management System for medical devices

•Good Manufacturing Practises (GMP)

•Control of documents and records

•Internal audits (ISO or FDA)

•Quality tools - COVER, 5 Whys, Pareto, Fishbone

•MS Office, Excel and ERP systems (e.g. SAP)

⸻

3. How to specialise online (and for free)

Free and affordable courses:

•Coursera - "Medical Device Regulation in Europe" (University of Copenhagen)

Direct link - Free with paid option for certificate.

•Khan Academy - Statistics and probability

Https://pt.khanacademy.org/math/statistics-probability

• FutureLearn - "Good Manufacturing Practice (GMP)" (NSF International)

Https://www.futurelearn.com/courses/good-manufacturing-practice

• edX - "Introduction to Quality Management"

Https://www.edx.org/course/introduction-to-quality-management

•LinkedIn Learning (free for 1 month)

Search for: "Quality Assurance", "ISO 13485" or "CAPA Process"

#QualityAssurance

#QAJobs

#QualityControl

#QualityEngineer

#QACareers

#QualityManagement


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