Medical Device Quality Assurance Specialist
2 dagen geleden
Role Overview
We are seeking a highly skilled Medical Device Quality Assurance Specialist to join our team at Yacht. In this role, you will play a critical part in ensuring the safety and quality of medical devices, directly impacting global patient care and customer satisfaction.
About the Role
This position involves driving the Correction & Removal (C&R) strategy, ensuring compliance with global regulatory standards. You will prepare documents to support critical C&R decisions, including Health Hazard Evaluations. Additionally, you will create and manage all C&R-related customer notifications and regulatory submissions, such as FSCA and 21CFR806.
Main Responsibilities
Develop and implement the C&R strategy to ensure compliance with regulatory requirements.Prepare documents to support critical C&R decisions, including Health Hazard Evaluations.Create and manage C&R-related customer notifications and regulatory submissions.Manage C&R documentation to meet Good Documentation Practices.Support responses to inquiries from regulatory agencies.Monitor and track C&R progress, sharing updates with stakeholders.Collaborate with C&R teams to improve processes continuously.Benefits and Conditions
Primary Employment Conditions
A competitive salary, based on industry standards, classification depending on education and work experience; 13th month salary paid out periodically pro rata; 8.33% holiday pay calculated over 12 monthly salaries.
Secondary Employment Conditions
Pension Plus scheme, build-up from day 1; Net €750 for setting up your home workplace; 25 days of vacation per year based on 40 hours; travel expenses reimbursement; options for working from home with a home work allowance; Yacht Academy with a training budget of up to €3,500 per year; referral bonuses up to €1,500; fixed HR contact person for personal guidance; a professional buddy; knowledge & networking events.
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