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For Companies At a Glance
- Tasks: Manage quality systems, oversee audits, and ensure compliance in a medical device company.
- Company: Join a rapidly growing medical device manufacturer with global expansion plans.
- Benefits: Competitive salary, bonuses, and opportunities for professional growth.
- Why this job: Be part of a dynamic team impacting healthcare while developing your career in quality assurance.
- Qualifications: Experience in QA within medical devices, degree in a scientific field, strong problem-solving skills.
- Other info: Exciting growth ahead with product approval in the US and site expansion planned.
The predicted salary is between 48000 - 84000 £ per year.
Senior Quality Assurance Engineer
Base salary £60,000 – 70,000, plus additional bonuses
West Lothian area
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 are 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 are under going 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 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 a 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 (url removed) for more information!
Senior Manufacturing Quality Engineer employer: Entrust Resource Solutions
Contact Detail:
Entrust Resource Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manufacturing Quality Engineer
✨Tip Number 1
Familiarise yourself with ISO 13485 and other relevant regulatory standards. Being able to discuss these in detail during your interview will demonstrate your expertise and commitment to quality assurance in the medical device industry.
✨Tip Number 2
Prepare examples of how you've successfully managed quality management systems or led compliance projects in the past. Specific anecdotes can help illustrate your problem-solving skills and ability to handle multiple stakeholders.
✨Tip Number 3
Research the company’s recent developments, especially their expansion plans and product approvals. 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.
✨Tip Number 4
Network with professionals in the medical device field, particularly those with experience in quality assurance. Engaging with industry contacts can provide valuable insights and potentially lead to referrals that enhance your application.
We think you need these skills to ace Senior Manufacturing Quality Engineer
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 industry. Emphasise your familiarity with ISO 13485 and any relevant qualifications.
Craft a Compelling Cover Letter: Write a cover letter that showcases your problem-solving abilities and your experience managing multiple stakeholder groups. Mention specific examples of how you've contributed to quality management systems in previous roles.
Highlight Key Responsibilities: In your application, clearly outline your experience with batch release processes, internal audits, and customer complaint handling. This will demonstrate your capability to manage the key responsibilities mentioned in the job description.
Showcase Continuous Improvement Projects: Discuss any continuous improvement projects you have led or been involved in, particularly those related to regulatory compliance and risk assessments. This will show your proactive approach to quality assurance.
How to prepare for a job interview at Entrust Resource Solutions
✨Showcase Your Experience
Make sure to highlight your extensive experience in Quality Assurance, particularly within the medical device or pharmaceutical industry. Be prepared to discuss specific projects where you successfully managed quality systems or compliance issues.
✨Understand ISO 13485
Since ISO 13485 is a key requirement for this role, brush up on its principles and how they apply to quality management systems. Be ready to explain how you've implemented these standards in your previous roles.
✨Demonstrate Problem-Solving Skills
Prepare examples that showcase your strong problem-solving abilities. Think of situations where you identified a quality issue and the steps you took to resolve it, especially in a fast-paced environment.
✨Engage with Stakeholders
This role requires managing multiple stakeholder groups, so be ready to discuss your experience in engaging with different levels of an organisation. Share examples of how you've effectively communicated and collaborated with both operators and executive management.
