Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead Quality Control and Engineering teams, ensuring compliance and continuous improvement.
- Company: Join an innovative Medical Device Company in West Yorkshire with a cutting-edge product.
- Benefits: Enjoy a dynamic work environment with opportunities for professional growth and development.
- Why this job: Be part of a team making a real impact in healthcare through quality engineering.
- Qualifications: Minimum 6 years in management within an ISO13485 environment; strong leadership and communication skills required.
- Other info: ISO13485 accreditation is essential; applications from those with relevant experience only.
The predicted salary is between 36000 - 60000 £ per year.
Aurora Lifesciences are proud to partner with an innovative Medical Device Company based in West Yorkshire to onboard their next critical hire for Quality Engineering Manager. This is an amazing opportunity to join a company that has developed a cutting-edge medical device product where the market acceptance for the device has grown YoY.
This role will involve the successful candidate managing the day-to-day duties and priorities for the Quality Control and Quality Engineering teams. You will be proficient in utilising continuous improvement techniques in conjunction with cross-site departments to streamline and simplify the Quality Management System processes and procedures.
As Quality Engineering Manager, you will manage and lead non-conformance investigations and document containment, root cause investigations. Furthermore, you will provide technical leadership for a range of quality engineering activities including process change control, non-conformance investigations, SCARs, CAPA, quality continuous improvement projects and programmes.
Key Responsibilities- Responsible for tracking Quality Control and Quality Engineering key performance indicators, for performance and performs quality trend analysis for quality operations; develops scorecards to drive continuous improvement.
- Provides technical support for risk analysis for PFMEA and DFMEAs risk assessments associated with change, non-conformance and customer feedback as per the requirements of ISO 14971: 2019.
- Remain up to date with impending changes and developments regarding quality compliance requirements as per ISO13485 MDR 2017/745.
- Provides technical support for process validation (IQ, OQ, PQ) and qualification activities as per the requirements of ISO 13485 MDR 2017/745 and 21CFR820.
- Manage and provide technical support to Quality Engineering team to ensure that all processes are validated per the Validation Master Plan, applicable procedures, and regulatory requirements as per the requirements of ISO13485 MDR 2017/745.
- Responsible for receiving inspection processes.
- Minimum of 6 years’ experience within a management and leadership role in an ISO13485 environment.
- Working knowledge of European and US Quality System requirements (ISO13485 MDR 2017/745 and 21CFR820).
- Proven track record leading cultural change.
- Working knowledge of validations; nonconformance resolution; CAPA; and continuous improvement.
- Thorough knowledge of inspection first principle measurement techniques and quality engineering/assurance principles.
- Thorough knowledge of ISO14971 risk management of medical devices.
- Thorough knowledge of Lean principles and 6-sigma tools.
- Proven track record leading and managing teams, quality system and process improvement projects/programmes, and driving change initiatives.
- Strong verbal and written communication & presentation skills; comfortable presenting to all levels of an organisation.
The Company are ISO13485 accredited so can only accept applications from those that have worked to this standard.
Quality Engineering Manager employer: Aurora Lifesciences
Contact Detail:
Aurora Lifesciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineering Manager
✨Tip Number 1
Familiarise yourself with ISO 13485 and ISO 14971 standards, as these are crucial for the role. Understanding the nuances of these regulations will not only help you in interviews but also demonstrate your commitment to quality management.
✨Tip Number 2
Showcase your experience with continuous improvement techniques like Lean and Six Sigma. Be prepared to discuss specific projects where you've successfully implemented these methodologies to enhance quality processes.
✨Tip Number 3
Highlight your leadership skills by preparing examples of how you've managed teams and driven cultural change in previous roles. This will be key in demonstrating your ability to lead the Quality Engineering team effectively.
✨Tip Number 4
Network with professionals in the medical device industry, especially those familiar with quality systems. Engaging with others in the field can provide insights and potentially valuable connections that may help you land the job.
We think you need these skills to ace Quality Engineering Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in quality engineering and management, particularly within an ISO13485 environment. Use specific examples that demonstrate your leadership skills and familiarity with quality systems.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your enthusiasm for the role. Mention how your background aligns with the company's innovative approach to medical devices and your commitment to continuous improvement.
Highlight Relevant Experience: In your application, emphasise your experience with non-conformance investigations, CAPA, and quality continuous improvement projects. Be specific about your achievements and how they relate to the responsibilities of the Quality Engineering Manager role.
Showcase Communication Skills: Since strong verbal and written communication skills are essential for this role, consider including examples of presentations or reports you've delivered. This will demonstrate your ability to communicate effectively at all levels of an organisation.
How to prepare for a job interview at Aurora Lifesciences
✨Showcase Your Leadership Skills
As a Quality Engineering Manager, you'll need to demonstrate your ability to lead teams effectively. Prepare examples of how you've successfully managed teams in the past, focusing on your leadership style and how you foster a culture of continuous improvement.
✨Understand ISO Standards Thoroughly
Given the importance of ISO13485 and other regulatory standards in this role, make sure you're well-versed in these requirements. Be ready to discuss how you've applied these standards in previous roles and any challenges you've faced in compliance.
✨Prepare for Technical Questions
Expect to be asked about specific quality engineering concepts such as CAPA, SCARs, and risk management. Brush up on these topics and be prepared to explain your experience with them, including any relevant projects or outcomes.
✨Demonstrate Continuous Improvement Mindset
The company values continuous improvement, so come prepared with examples of how you've implemented process improvements in the past. Discuss the tools and methodologies you've used, such as Lean or Six Sigma, and the impact they had on quality outcomes.
