19th Ave New York, NY 95822, USA

QMS Specialist (Medical Devices)

MAK SYSTEM International Group

Job role: QMS Specialist (Medical Devices)

Country: North Macedonia or Serbia              

Reporting to: QMS Specialist (Medical Devices)


A typical day might include:

  • 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

Your key relationships will be:

  • Head of Quality Assurance
  • Chief Operating Officer and QARAC
  • Developers and Head of Product Engineering
  • Project Managers

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
  • Care passionately about ensuring the safety of our customers’ patients
  • 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

You will have:

  • 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.;

You may have (nice to have but not essential):

  • A Bachelors degree, preferably in a related discipline

If you are interested, please send your application at: jobs.mk@mak-system.net; D.Kiprijanovska@mak-system.net

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