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For Companies At a Glance
- Tasks: Manage quality systems, handle customer complaints, and ensure compliance with industry standards.
- Company: Join a leading and rapidly growing medical device manufacturer making a global impact.
- Benefits: Enjoy a competitive salary, bonuses, and opportunities for professional growth.
- Why this job: Be part of a dynamic team focused on innovation and quality in healthcare.
- Qualifications: Extensive QA experience in medical devices or pharmaceuticals is essential.
- Other info: Experience in aseptic manufacturing is a plus.
The predicted salary is between 60000 - 70000 £ per year.
We are seeking a highly experienced and skilled Quality Assurance Engineer to join a leading medical device business as they expand their product globally. The business is a successful and rapidly growing medical device manufacturer. After identifying several areas for growth in the business, the Quality Assurance Team is undergoing expansion to account for this.
As a brief synopsis, you will be responsible for:
- Managing key elements of the Quality Management System
- Batch Release
- Ensuring compliance to applicable standards across all levels of the business
- Generating and reporting of quality KPIs to Site Head
- Managing the Customer Complaint handling through to resolution
- Performing post-market surveillance planning and reporting
- Providing quality guidance on continuous improvement projects including change management and risk assessments
- Leading regulatory compliance projects, supporting gap analysis and action closure to ensure compliance to regulatory standards
Extensive experience within a QA role within a medical device, pharmaceutical or closely related industry is required. Previous experience working in an aseptic manufacturing facility is desirable.
Quality Specialist - Medical Devices employer: Entrust Resource Solutions
Contact Detail:
Entrust Resource Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Specialist - Medical Devices
✨Tip Number 1
Familiarise yourself with the specific regulations and standards that govern the medical device industry, such as ISO 13485 and FDA regulations. This knowledge will not only help you in interviews but also demonstrate your commitment to quality assurance.
✨Tip Number 2
Network with professionals in the medical device sector through LinkedIn or industry events. Engaging with current employees can provide insights into the company culture and expectations, which can be invaluable during the interview process.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed quality KPIs and handled customer complaints in your previous roles. Being able to articulate your experience with tangible results will set you apart from other candidates.
✨Tip Number 4
Stay updated on the latest trends and technologies in the medical device field. Showing that you are proactive about continuous learning can impress interviewers and highlight your dedication to quality improvement.
We think you need these skills to ace Quality Specialist - Medical Devices
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your extensive experience in Quality Assurance, particularly within the medical device or pharmaceutical industries. Emphasise any specific roles or projects that relate to managing Quality Management Systems and regulatory compliance.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Discuss how your background aligns with their needs, particularly in areas like customer complaint handling and post-market surveillance. Use specific examples to demonstrate your skills.
Highlight Relevant Achievements: When detailing your experience, focus on quantifiable achievements. For instance, mention any KPIs you have successfully managed or improvements you have implemented in previous roles that led to enhanced compliance or efficiency.
Proofread Your Application: Before submitting, carefully proofread your application materials. Look for any spelling or grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial in a QA role.
How to prepare for a job interview at Entrust Resource Solutions
✨Know Your Quality Standards
Familiarise yourself with the key quality standards relevant to the medical device industry, such as ISO 13485 and FDA regulations. Be prepared to discuss how you have applied these standards in your previous roles.
✨Demonstrate Problem-Solving Skills
Prepare examples of how you've successfully managed customer complaints or resolved quality issues in the past. Highlight your analytical skills and ability to implement effective solutions.
✨Showcase Continuous Improvement Experience
Be ready to talk about your involvement in continuous improvement projects. Discuss specific initiatives you've led or contributed to, focusing on the outcomes and benefits achieved.
✨Prepare for Regulatory Compliance Questions
Expect questions related to regulatory compliance and risk assessments. Brush up on your knowledge of gap analysis and be prepared to explain how you've ensured compliance in previous positions.
