Quality Assurance Coordinator supporting Supply Chain Logistics in contact lens production. Ensuring quality standards compliance and managing quality documentation in the European Distribution Center.
About the role
- QA & RA Officer ensuring compliance in Quality Management Systems for Nicolab's medical devices. Responsible for registrations and audits in various international markets.
Responsibilities
- Maintain compliance of Nicolabs QMS processes ;
- Update Nicolab’s QMS for new markets ;
- Organize internal & external audits ;
- Handling of Complaints, Nonconformities and CAPAs ;
- Manage Document Control ;
- Support Product labelling ;
- Organize management review ;
- Vigilance reporting ;
- Ensure upkeep of Nicolab’s current international product registrations ;
- Support registrations of new products and registration in new markets by:
- Developing regulatory strategies
- Assembling of technical documentation
Requirements
- BSc degree or higher in science, engineering, medicine, law or language;
- 1+ years of experience as Quality and Regulatory Officer in software as a Medical device or related field;
- Knowledge and experience with ISO 13485 Quality Management Systems;
- Knowledge and experience with regulatory submissions and registration maintenance (MDR, FDA etc.);
- Attention to detail;
- Affinity to regulations and processes;
- Excellent communication skills in English, written and oral, additional languages are a plus;
Benefits
- Chance to make a real difference in patients' lives
- Work in a stimulating environment with a motivated team
- Flexible Employment Agreement: Part time / Fulltime / Remote (EOR Contract*)
- Flexible working hours
- Flexible paid time off*
- Remote work policy
- Laptop + home office/IT equipment*
- Commuting to work - costs reimbursement
- Pension plan scheme*
- Employee Stock Option Plan (ESOP)*
- Corporate programs including Employee Referral Program with rewards
- Learning & Development opportunities including in-house training and coaching, professional certifications, and over 22,00 courses on LinkedIn Learning Solutions and much more *All benefits and perks are subject to certain eligibility requirements
Job title
Job type
Experience level
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Not specified
Degree requirement
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