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For Companies At a Glance
- Tasks: Lead audits and ensure quality standards in medical device manufacturing.
- Company: Join a growing medical device company known for its commitment to quality and innovation.
- Benefits: Enjoy competitive pay, career growth opportunities, and a supportive work environment.
- Why this job: Be part of a dynamic team making a real impact in healthcare.
- Qualifications: Degree in Engineering or relevant science; experience in QA roles in medical devices required.
- Other info: MCS Group offers a 4.9-star service rating and a variety of job opportunities.
The predicted salary is between 36000 - 60000 £ per year.
MCS Group is delighted to be partnering with our medical device client to recruit a Senior QA/RA Specialist based in Ballymena. Due to business growth, this excellent opportunity has become available.
As the Senior QA/RA Specialist you will:
- Manage Notified Body / Regulatory Agency audits
- Carry out and review the results of quality audits which appraise the effectiveness and applicability of the QMS
- Compile materials for license renewals, updates, and registrations
- Maintain product EU technical files
- Post-market surveillance planning and follow-up activities
- Be an integral QA team member in maintaining the company's internal procedures, SOP's and ISO13485:2016 certification
The successful candidate:
- Degree in Engineering / Biological or Other Relevant Science or equivalent work experience
- Relevant experience in a manufacturing QA role obtained in a Medical Device or In Vitro Diagnostic Device professional or OTC environment
- Current working knowledge of ISO 14971, and ISO 13485:2016 as well as European regulations for Medical and In Vitro Diagnostic devices
To speak in absolute confidence about this opportunity please send an up to date CV via the link provided or contact Kathy Donaghey Senior Specialist Consultant at MCS Group 028 96 93 5521.
Even if this position is not right for you, we may have others that are. Please visit MCS Group to view a wide selection of our current jobs.
Senior QA/RA Specialist employer: MCS Group
Contact Detail:
MCS Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior QA/RA Specialist
✨Tip Number 1
Familiarise yourself with the latest updates in ISO 13485:2016 and ISO 14971. Being well-versed in these standards will not only boost your confidence during interviews but also demonstrate your commitment to quality assurance in the medical device sector.
✨Tip Number 2
Network with professionals in the QA/RA field, especially those who work in medical devices. Attend industry events or join relevant online forums to connect with others and gain insights that could give you an edge in your application.
✨Tip Number 3
Prepare for potential interview questions by reviewing common scenarios related to regulatory audits and quality management systems. Think of specific examples from your past experience that showcase your problem-solving skills and knowledge in these areas.
✨Tip Number 4
Research MCS Group and their client’s values and mission. Tailoring your conversation to align with their goals during the interview can help you stand out as a candidate who is genuinely interested in contributing to their success.
We think you need these skills to ace Senior QA/RA Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Senior QA/RA Specialist. Familiarise yourself with the key tasks mentioned in the job description, such as managing audits and maintaining technical files.
Tailor Your CV: Customise your CV to highlight relevant experience in quality assurance and regulatory affairs within the medical device sector. Emphasise your knowledge of ISO standards and any specific achievements that align with the job requirements.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and regulatory compliance. Mention specific experiences that demonstrate your ability to manage audits and maintain QMS effectively.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a QA role.
How to prepare for a job interview at MCS Group
✨Know Your Regulations
Familiarise yourself with ISO 13485:2016 and ISO 14971, as well as the relevant European regulations for medical devices. Be prepared to discuss how your experience aligns with these standards and how you can contribute to maintaining compliance.
✨Showcase Your Audit Experience
Highlight your experience managing Notified Body and Regulatory Agency audits. Be ready to provide examples of how you've successfully navigated audits in the past and what you learned from those experiences.
✨Demonstrate Quality Management Skills
Discuss your experience with quality audits and how you've appraised the effectiveness of Quality Management Systems (QMS). Prepare to explain specific instances where your contributions led to improvements in quality processes.
✨Prepare for Technical Questions
Expect technical questions related to post-market surveillance and the maintenance of EU technical files. Brush up on your knowledge of these areas and be ready to discuss how you would approach these tasks in the role.
