As a quality assurance engineer, you will be a management representative, reporting to the CEO.

Responsibilities will include:

• Define and implement the quality management system
• Authority of final approval of in-process inspections, lot release for clinical use, work instructions, operating procedures etc.
• Participate in design of the manufacturing and verification processes
• Represent the company in quality related matters, such as audits
• Manage all quality and product records
• Manage controlled measurement devices in production environment
• Initiate and manage ECOs, CAPAs, NTFs etc.

REQUIREMENTS

MINIMUM REQUIREMENTS

• B.Sc. in engineering or life sciences
• 2 years’ full-time experience in the medical device industry
• High English reading & writing proficiency
• Fluency with ISO 13485 and 21 CFR Part 820

PRIORITY REQUIREMENTS

• Experience with regulatory submissions of class III medical device
• FDA / Notified Body audits
• ISO 13485 first time certification
• Standards and regulations for cardiovascular implants and delivery systems