About the job
We are looking for a Senior Quality Assurance Compliance Specialist to join our compliance and RA team, which plays a central role in both pre-market and post-market activities. The team is responsible for regulatory activities, quality management system, and ensuring compliance with applicable standards, including those related to privacy.
The Quality Assurance Compliance Specialist will play an important role in the companys regulatory, quality and compliance activities, such as ensuring compliance with relevant quality standards (including ISO 13485:2016, 21 CFR 820, MDSAP and IVDR); supporting internal audits, corrective efforts and different quality projects; and defining quality procedures, protocols and tools.
What youll be doing
Provide ongoing support for the companys quality management activities, including SDLC, PMS, product investigation, operations, training management, supplier management, and document control
Maintain the companys quality management system (QMS)
Evaluate and address quality assessment related to customer complaints
Prepare and maintain technical documentation in compliance with standards such as ISO 13485, 21 CFR 820, and IVDR
Collaborate with cross-functional teams, including R&D, product development, and technical support on quality-related activities
Perform privacy-related tasks, such as evaluating suppliers for privacy compliance and reviewing data processing agreements (DPAs)
Analyze post-market surveillance data to support company initiatives
Prepare teams for internal and external audits
Bachelor's degree in industrial engineering, biotechnology engineering, life science/exact science, or law
At least 5 years of experience working with the QMS of a medical device company, including development, implementation, or compliance with standards such as ISO 13485 and FDA regulations
Understanding of QA processes and methodologies (ISO 13485:2016, 21 CFR 820 or similar)
Understanding of privacy requirements such as HIPAA, GDPR and ISO27799
Ability to collaborate effectively with cross-functional teams to achieve quality objectives
A motivated, collaborative, and proactive approach to work
Team orientation
Excellent communication skills (both written and verbal)
Strong attention to detail
Ability to lead and implement processes
English proficiency
