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- Tasks: Manage quality systems, oversee audits, and ensure compliance in a medical device company.
- Company: Join a leading and rapidly growing medical device manufacturer with global expansion plans.
- Benefits: Competitive salary, bonuses, and opportunities for professional growth in a dynamic environment.
- Why this job: Be part of a crucial team driving quality in innovative medical products with a significant impact.
- Qualifications: Extensive QA experience in medical devices, degree in a scientific field, and strong problem-solving skills.
- Other info: Exciting growth ahead with product approval in the US and site expansion planned for 2025.
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. This role carries high responsibility, sitting directly beneath the site Head of QA. The business is a successful and rapidly growing medical device manufacturer. With a planned site expansion coming up, and approval for their product in the US within touching distance, they have a huge 2025 ahead. 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, and ensuring compliance to applicable standards across all levels of the business.
Further Key Responsibilities:
- Oversee the Material Review Board and disposition products
- A member of the internal audit team - conducting process, product, and workplace audits
- Responsibility for generating and reporting of quality KPIs to Site Head
- Manage the Customer Complaint handling through to resolution
- Perform post-market surveillance planning and reporting
- Provide expert guidance and knowledge to technical and validation teams
- Provide quality guidance on continuous improvement projects including change management, and risk assessments
- Lead regulatory compliance projects, supporting gap analysis and action closure to ensure compliance to regulatory standards
- Provide support to management during notified body audits and subsequent closure
Key Requirements:
- Extensive experience within a QA role within the medical device or pharmaceutical industry (experience with ISO 13485 required)
- Degree in scientific field or equivalent qualifications
- Strong problem-solving ability
- The ability to manage multiple stakeholder groups from operators to executive management
Apply now by hitting 'Easy Apply' or email dion@entrustrs.com for more information!
Senior Quality Assurance Specialist employer: Entrust Resource Solutions
Contact Detail:
Entrust Resource Solutions Recruiting Team
dion@entrustrs.com
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Assurance Specialist
✨Tip Number 1
Familiarise yourself with ISO 13485 and other relevant regulations in the medical device industry. Being well-versed in these standards will not only boost your confidence during interviews but also demonstrate your commitment to quality assurance.
✨Tip Number 2
Network with professionals in the medical device sector, especially those who work in quality assurance roles. Attend industry events or join online forums to gain insights and potentially get referrals that could help you land the job.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed quality management systems and handled customer complaints in your previous roles. Real-life scenarios can showcase your problem-solving skills and experience effectively.
✨Tip Number 4
Research the company’s recent projects and expansions, particularly their plans for 2025. Showing that you understand their business goals and challenges will set you apart as a candidate who is genuinely interested in contributing to their success.
We think you need these skills to ace Senior Quality Assurance Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Senior Quality Assurance Specialist position. Familiarise yourself with key terms like Quality Management System and ISO 13485, as these will be crucial in your application.
Tailor Your CV: Customise your CV to highlight relevant experience in quality assurance within the medical device or pharmaceutical industry. Emphasise your problem-solving skills and any specific achievements related to compliance and audits.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and your understanding of the medical device sector. Mention how your background aligns with the company's goals and your excitement about their upcoming expansion.
Proofread and Edit: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects your attention to detail, which is essential for a role in quality assurance.
How to prepare for a job interview at Entrust Resource Solutions
✨Know Your Standards
Familiarise yourself with ISO 13485 and other relevant quality standards. Be prepared to discuss how your experience aligns with these standards and how you have implemented them in previous roles.
✨Showcase Your Problem-Solving Skills
Prepare examples of complex problems you've solved in past QA roles, particularly in the medical device or pharmaceutical industry. Highlight your analytical thinking and how it led to successful outcomes.
✨Understand the Business Context
Research the company’s recent developments, especially their expansion plans and product approvals. This will help you demonstrate your interest in the role and how you can contribute to their growth.
✨Prepare for Stakeholder Management Questions
Think about your experiences managing various stakeholders, from operators to executive management. Be ready to discuss specific instances where you successfully navigated differing priorities and achieved consensus.
