Quality Assurance Engineer
2 weeks ago
QUALITY ASSURANCE ENGINEER (Medical Devices/ISO13485)
PROJECTUS
Permanent Position
ROLE OVERVIEW:
Are you ready to take on a new challenge in the Medical Devices sector?
Have you reached a standstill in your current role?
Are you looking for greater responsibilities but feel limited by your current organization's size?
This is your opportunity.
PROJECTUS is a prominent entity in the industry, focusing on innovative solutions for advancing medical conditions. Your skills are essential.
As the primary Quality Assurance Engineer, you will manage 2-3 critical projects within the organization, taking full responsibility.
You will work closely with Quality Managers to propel new product initiatives and related projects.
Your main focus will be on improving product quality; you will conduct root cause analysis and lead corrective and preventive actions.
Additionally, you will oversee the protocols, policies, and systems for the final inspection of components and finished products.
You will also participate in the complaint management process and collaborate with various departments to identify and implement corrective actions.
A strong quality management system is vital for any medical device organization, and you will play a key role in sustaining and enhancing this system.
Being knowledgeable in internal and external audits is crucial for a quality assurance engineer like you.
ESSENTIAL SKILLS/EXPERIENCE:
- Bachelor's degree in engineering or a related field
- 2-5 years of relevant experience (5+ years for Senior Quality Assurance Engineer)
- Experience in Cardiovascular Medical Device environments (e.g., ISO 13485)
- Familiarity with Class 3 medical devices is highly beneficial
- Understanding of process control requirements for both domestic and international product distribution
- Proficient in QMS/eQMS and Microsoft Office Suite
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