Are you a quality assurance professional looking for a new challenge? 🌐 We’re hiring a QA Specialist to join our team and contribute to maintaining our quality management system. This is a great opportunity to work with a dynamic team and ensure the quality and safety of medical devices. 💼
About the Role 🌟
As a QA Specialist, you will be responsible for planning, conducting, and documenting internal audits, managing the complaint handling process, and conducting post-market surveillance. You will also support management review meetings and perform trend analysis using data from complaints, audits, and post-market feedback. 📊
Key Responsibilities 📝
- Internal Audits: Plan, conduct, and document internal audits in accordance with the annual audit schedule.
- Complaint Handling: Manage the complaint handling process, including data collection, investigation, root cause analysis, and timely resolution.
- Post-Market Surveillance: Conduct post-market surveillance to identify trends, potential risks, and improvement opportunities.
- Documentation: Maintain documentation in compliance with ISO 13485, FDA, and other applicable regulatory standards.
- Trend Analysis: Perform trend analysis using data from complaints, audits, and post-market feedback to identify recurring issues, potential risks, and opportunities for quality improvement.
Desired Skills and Education 📚
- Education: Bachelor’s or Master’s degree in Biomedical Engineering or related field.
- Experience: Minimum 1 year of experience in medical device quality assurance, with exposure to regulatory affairs preferred.
- Regulatory Knowledge: Strong working knowledge of ISO 13485:2016, ISO 14971, EU MDR, and basic working knowledge of MDSAP and FDA QMSR (aligned with 21 CFR Part 820).
- Communication Skills: Strong written and verbal communication skills in English.
What We Offer 🌈
- Opportunity to work with a dynamic team: Collaborate with a team of experienced professionals in the medical device industry.
- Career Growth: Opportunities for career growth and professional development.
- Competitive Benefits: Competitive salary and benefits package.
How to Apply 📧
If you’re interested in this exciting opportunity, send your updated resume to mailto:lisa@elexes.com. Don’t miss this chance to join our team and contribute to the quality and safety of medical devices! 🌟
Tips for Applicants 📝
- Tailor Your Resume: Make sure your resume highlights your relevant experience and skills.
- Show Enthusiasm: Demonstrate your passion for quality assurance and your ability to work in a team.
- Be Prepared: Be prepared to discuss your experience and qualifications.
Conclusion 🌟
Don’t miss this opportunity to join our team and contribute to the quality and safety of medical devices. Apply now and take the first step towards a rewarding career in quality assurance! 🚀
