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- Tasks: Lead Quality Control and Engineering teams, ensuring top-notch quality management.
- Company: Join an innovative Medical Device Company in West Yorkshire with a cutting-edge product.
- Benefits: Enjoy a dynamic work environment with opportunities for continuous improvement and professional growth.
- Why this job: Be part of a team making a real impact in healthcare with a focus on quality and innovation.
- Qualifications: 6+ years in management within an ISO13485 environment; strong leadership and quality assurance skills required.
- Other info: ISO13485 accreditation is essential; only applicants with relevant experience will be considered.
The predicted salary is between 43200 - 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 & presentation skills; comfortable presenting to all levels of an organisation.
The Company is 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 lead to referrals that could strengthen your application.
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 ISO13485 environments and your leadership roles. Use specific examples that demonstrate your proficiency in quality engineering and continuous improvement techniques.
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, particularly in managing quality control and engineering teams, and your experience with risk assessments and compliance.
Highlight Relevant Achievements: When detailing your work experience, focus on achievements that relate to the key responsibilities of the role. Include metrics or outcomes from your previous positions that showcase your ability to drive continuous improvement and manage non-conformance investigations.
Proofread Your Application: Before submitting, carefully proofread your application materials. Ensure there are no spelling or grammatical errors, and that all information is clear and concise. A polished application reflects your attention to detail, which is crucial in quality engineering.
How to prepare for a job interview at Aurora Lifesciences
✨Showcase Your Leadership Experience
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, particularly in an ISO13485 environment, and be ready to discuss specific challenges you faced and how you overcame them.
✨Understand Quality Management Systems
Familiarise yourself with the key components of Quality Management Systems, especially those relevant to ISO13485 and ISO14971. Be prepared to discuss how you've implemented continuous improvement techniques and streamlined processes in previous roles.
✨Prepare for Technical Questions
Expect technical questions related to risk assessments, non-conformance investigations, and CAPA processes. Brush up on your knowledge of PFMEA and DFMEA, and be ready to explain how you've applied these concepts in real-world scenarios.
✨Demonstrate Communication Skills
Strong communication skills are crucial for this role. Practice articulating your thoughts clearly and confidently, especially when discussing complex quality engineering topics. Be prepared to present your ideas as if you were addressing different levels within the organisation.
