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- Tasks: Lead quality assurance processes and manage compliance in a dynamic medical devices environment.
- Company: Join a global leader in medical devices, dedicated to eye health care products.
- Benefits: Enjoy a competitive salary, flexible working hours, bonuses, and generous holiday allowances.
- Why this job: Be part of an exciting expansion project and make a real impact in healthcare.
- Qualifications: Degree in engineering or science with extensive QA experience in medical devices or pharmaceuticals.
- Other info: Candidates must have the right to live and work in the UK.
Based in Livingston, Grw Talent’s client is part of a well-known global medical devices manufacturer. From their high-volume manufacturing site, they make controlled eye health care medical devices and products for customers across the world. Currently employing over 100 people in Scotland, the business continues to grow. Further potential expansion is being planned into new geographies including North America. As part of this expansion plan, they now need to make the key hire of a Senior Quality Assurance Engineer.
This is a site-based role, supporting a busy manufacturing site, standard hours are 37.5 per week, with flexible start/stop times and any excess weekly hours carried over to be taken in lieu.
Reporting to the Head of Quality Assurance, the Senior Quality Assurance Engineer will be responsible for managing key elements of the Quality Management System (QMS), Batch Release and ensuring compliance to applicable standards. This is a prominent role in the business working closely with staff at all levels of the organisation. You will take a prominent role leading/driving internal and external ISO 13485 and MHRA audits. There are a number of key projects led and supported by the quality team that need to be delivered as part of this role.
Key responsibilities will include:
- Manage QMS processes, including NC, CAPA and Change control
- Perform Batch Release of all products
- 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 Senior Management
- 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
Educated to degree calibre in an engineering or scientific discipline, we are looking for proven and highly experienced medical device, life sciences or pharmaceutical Quality Assurance, Senior Quality Assurance, Principal Quality Assurance Engineers or QA Specialists. All candidates should have strong experience leading or closely supporting ISO13485/MHRA audits, driving QA projects across a business and leading/coaching/mentoring junior colleagues in the QA function. Exposure to leading or managing supplier audits and/or a knowledge of FDA accreditation would be a distinct advantage.
This role represents an excellent opportunity for an experienced Quality Assurance specialist who wants to join a large site and geography expansion project. Great opportunity to lead from the front and play an integral role across multiple functions in the business. Your base salary of £53-69,000 is complemented by personal and site-wide bonus schemes, flexible working arrangements, generous holiday and pension contributions.
Candidates must be able to live and work freely in the UK.
To apply please send your resume to our recruitment partner Bruce Hydes at Grw Talent.
Senior Quality Assurance Engineer employer: CV-Library
Contact Detail:
CV-Library Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Assurance Engineer
✨Tip Number 1
Familiarise yourself with ISO 13485 and MHRA regulations, as these are crucial for the role. Understanding the nuances of these standards will not only help you in interviews but also demonstrate your commitment to quality assurance in the medical devices sector.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience in quality assurance. Engaging with them on platforms like LinkedIn can provide insights into the company culture and expectations, which can be invaluable during your application process.
✨Tip Number 3
Prepare to discuss specific examples of how you've led or supported ISO audits in your previous roles. Being able to articulate your hands-on experience will set you apart from other candidates and show that you can hit the ground running.
✨Tip Number 4
Research the company’s recent projects and expansion plans. Showing that you understand their business goals and how your role as a Senior Quality Assurance Engineer fits into those plans can make a strong impression during interviews.
We think you need these skills to ace Senior Quality Assurance Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Assurance, particularly in the medical devices or pharmaceuticals sector. Emphasise your familiarity with ISO 13485 and MHRA audits, as well as any leadership roles you've held.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the key responsibilities mentioned in the job description. Explain how your background aligns with managing QMS processes, conducting audits, and leading QA projects.
Highlight Key Achievements: In both your CV and cover letter, include specific examples of past achievements in Quality Assurance. Use metrics where possible to demonstrate your impact, such as improvements in compliance rates or successful audit outcomes.
Proofread Your Application: Before submitting, carefully proofread your application for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in a Quality Assurance role.
How to prepare for a job interview at CV-Library
✨Understand the Quality Management System (QMS)
Familiarise yourself with the key elements of a QMS, especially in the context of medical devices. Be prepared to discuss your experience managing QMS processes like NC, CAPA, and change control, as these are crucial for the role.
✨Showcase Your Audit Experience
Highlight your experience with ISO 13485 and MHRA audits. Be ready to provide examples of how you've led or supported audits in the past, and discuss any challenges you faced and how you overcame them.
✨Demonstrate Leadership Skills
Since this role involves mentoring junior colleagues, be prepared to talk about your leadership style. Share specific instances where you've coached or guided team members, and how that contributed to successful QA projects.
✨Prepare for Regulatory Compliance Questions
Expect questions related to regulatory compliance and your experience with FDA accreditation. Brush up on relevant regulations and be ready to discuss how you've ensured compliance in previous roles.
