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- 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 that drives quality in life-saving medical devices and makes a real impact.
- Qualifications: Minimum 6 years in management within an ISO13485 environment; strong leadership and communication skills required.
- Other info: ISO13485 accreditation is essential; applications from non-compliant backgrounds will not be considered.
The predicted salary is between 48000 - 72000 £ 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 the 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 & presentations 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
Network with professionals in the medical device industry, especially those who have experience in quality engineering. Attend relevant conferences or webinars to make connections and gain insights that could give you an edge during the hiring process.
✨Tip Number 3
Prepare to discuss specific examples of how you've implemented continuous improvement techniques in previous roles. Highlighting your hands-on experience with Lean principles and Six Sigma tools will showcase your ability to drive change effectively.
✨Tip Number 4
Research the company’s recent developments and their product offerings. Being knowledgeable about their cutting-edge medical device will allow you to tailor your conversation and show genuine interest during interviews.
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 compliance requirements.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention how your background aligns with their needs, especially your experience with continuous improvement techniques and managing quality control teams.
Highlight Relevant Experience: When detailing your work history, focus on your achievements related to non-conformance investigations, CAPA, and quality continuous improvement projects. Use metrics where possible to quantify your impact.
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 relevant standards in this role, make sure you are well-versed in these regulations. Be ready to discuss how you've applied these standards in previous roles and how you stay updated with changes in compliance requirements.
✨Prepare for Technical Questions
Expect to face technical questions related to quality engineering processes, such as CAPA, SCARs, and risk assessments. Brush up on your knowledge of these areas and be prepared to explain your approach to managing non-conformance investigations and process validations.
✨Demonstrate Continuous Improvement Mindset
The company values continuous improvement, so be prepared to discuss specific projects where you've implemented improvements. Highlight your experience with Lean principles and Six Sigma tools, and how these have positively impacted quality outcomes in your previous roles.
