QMS Specialist (Medical Devices)

QMS Specialist (Medical devices)

Our client is a company that specializes in designing and developing mission-critical healthcare information system solutions. The company is continuously investing in the development of their software solutions to shape healtcare of tomorrow using reliable, secured and scalable technology.

We are currently looking for QMS Specialist to join their team in Belgrade.

Job Description:

•  Working with the head of quality assurance, and managers across the business to identify and implement improvements to QA procedures, improve internal compliance, and implement corrective and preventive activities – including change controls, quality systems, product release procedures and other software life cycle controls
• Reviewing documentation to ensure accuracy, completeness, user friendliness, and compliance, including with GDPR
• Review documentation supporting GMP activities for accuracy, completeness and compliance
• Leading, coordinating, or performing deviation investigations
• Preparing registrations and certifications of new products for the EU and FDA
• Participating in internal and external audits, and implementing their recommendations
• Collecting, maintaining, and storing Quality System and medical device product records, including Device History Records, Design History File and Device Master Records
• Reviewing and evaluating customer complaints; supporting root cause determination and risk assessment
• Providing training to other parts of the business on Quality Management, and procedures
• Raising awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities

Job Requirements:

• At least 2 years’ experience working within a regulated industry in Quality Assurance (preferably medical device or pharma)

• Good understanding of quality regulations; ISO 9001, ISO 13485 and 21CFR820;
• Proficiency with Microsoft Office, including Microsoft Word, Excel, PowerPoint, etc. to perform critical job functions, trending, reporting metrics etc.;
• Bachelor degree, preferably in related discipline (nice to have but not essential)

This job might be for you if you:

• Have a strong eye for detail
• Enjoy improving how things are done, as well as making sure they get done
• Are good at rolling up your sleeves and getting things done
• Have good written, oral, and presentation skills in English
• Are a problem solver and critical thinker
• Are a strong team player, with good critical thinking skills