Quality Engineer

PERGO MEDİKAL İLAÇ SANAYİ AŞ

Do you like to be player of a winning team???
We are a newly established medical company, based on a previous vast experience gained in the same industry for over 35 years. We design, manufacture and market innovative, high quality single use healthcare products for international markets.

Pergo spirit is "Passion for Better". We encourage our employees to carry out their creative ideas in a team oriented, technological work environment. Above all, in Pergo we prioritize doing business with integrity and respect for our employees and all the parties we interact with.

If you are looking for a company, which is governed according to sound principals in all respect and managed professionally based on the science and technology, you can be sure that, your future with us will be in the safe hands.

Currently we are looking for a talented Regulatory Specialist.

Job Description:

• Establish, implement and maintain procedures and processes needed for the quality management system according to relevant international and national standards;
• Prepare monthly reports needed for the management review;
• Ensure the promotion of awareness of regulatory and customer requirements throughout the organization;
• Coordinate the internal quality management system and product audits;
• Coordinate the relations with all third party certification organizations and regulatory bodies;
• Coordinate all risk management activities related to the quality management system and medical devices;
• Regulatory registration and certification of the products in countries where operation is targeted.  (USA, Canada, South America, Europe, Australia);
• Reviewing and establishing the company quality goals each year.

Requirements:

• Minimum 2 years experience in relevant position; 
• Minimum 4 years University degree in engineering (preferably in bioengineering or medical engineering);
• Knowledge of testing and measurement systems;
• Proficiency in using statistical methods;
• Excellent organization, communication, data analysis skills;
• Proficiency with Microsoft Office products; knowledge of database applications;
• Fluency in English;
• Exceptional communication and presentation skills with the ability to convey complex issues clearly and the ability to persuade;
• Strong attention to detail.