Role Overview
We are seeking an experienced Senior Quality Systems Specialist, who will play a key role in the implementation and maintenance of our company's Quality Management System.
About the Role
In this position, you will be responsible for ensuring compliance with relevant regulations, maintaining and improving quality management systems, coordinating audit processes, and managing data to facilitate timely reporting.
Responsibilities:
1. Maintain Veryan Quality Systems' compliance with Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745 FDA QSRs & ISO13485 standards/li>
2. Maintenance and continuous improvement of the quality management systems./li>
3. Act as Coordinator for CAPA Complaints Temporary Authorization (Deviations) processes./li> Coordinate activities preparation management audits regulatory bodies ./ li > Manage Quality Systems data collection analysis facilitation timely generation Monthly Reports Review Data etc. / li > / ul >
h3 Job Requirements/h3
pIn order to succeed in this challenging yet rewarding position your background should include one or more among these:
h4 Skills & Qualifications:h4
lilicensed Engineer ScienceorQuality Assurance degree/lili TrainingQualificationISO134851401971MedicalDeviceRegulation2017745FDAQSRshighly desirablelilaminimum Diploma LevelEngineeringScienceQuality Assurance discipline h lil Five years experience relevent industry ex Experienced professionals training qualification highly valuable Benefit isnonameurable adaptable opportunity collaborative work atmosphere supportive dynamic team state-of-the-art facility liability insurance medical benefits career growth opportunities Advertandme23 ] ,