At a Glance
- Tasks: Support NCR/CAPA processes and drive quality improvements in a dynamic environment.
- Company: Join Terumo Aortic, a leader in medical equipment manufacturing.
- Benefits: Career development opportunities and a chance to make a real difference.
- Other info: Collaborative culture with a focus on innovation and compliance.
- Why this job: Be part of a growing team and enhance your skills in quality engineering.
- Qualifications: Relevant degree and experience in quality assurance within regulated industries.
The predicted salary is between 36000 - 60000 £ per year.
Terumo Aortic are currently looking to recruit a Quality Engineer (NCR/CAPA) to join our team. This role will provide Quality Engineering support to the NCR/CAPA processes including development of containment plans / investigation plans / root cause analysis / action plans / effectiveness plans and perform NCR/CAPA trend analysis. This is an excellent opportunity to truly make a difference whilst enjoying excellent career development.
Main responsibilities
- Maintain the management tools (trackers, electronic folder, etc) to ensure audit readiness
- Provide consultation and guidance on CAPA / NCR investigation, impact assessments, risk assessments, and ensure implementation of good documentation practices.
- Provide guidance and support for effective investigation and root cause analysis for new CAPAs / NCRs, working collaboratively with other functional areas as appropriate
- Act as CAPA team owner/facilitator throughout all phases of activities such as initiation, investigation, action plan and effectiveness
- Act as NCR team owner/facilitator throughout all phases of activities such as initiation, risk assessment, investigation and disposition.
- Provide guidance and support for effective implementation of corrective/preventive actions from CAPA / NCR investigations
- Provide guidance and support for robust effectiveness measurement of CAPA / NCR actions
- Maintain communication channels with the CAPA / NCR owners regarding time frames and progression updates.
- Support development of solution verification tools to validate CAPA / NCR action plans
- Working with other functional areas as appropriate, ensure appropriate containment actions are defined and communicated
- Generate and maintain trending data for the CAPA / NCR process and publish as part of QMS KPI dashboard Provide trending data and reports upon request to senior management, functional managers, regulatory authorities and customers
- Provide data trending information and status updates to the respective CAPA and NCR Review Boards
- In conjunction with the Risk Team, provide QE input to dFMEAs and pFMEAs, particularly with respect to CAPA / NCR data
- Identifying opportunities to improve processes through use of Lean Methodology or operational excellence principle and tools.
- Work towards meeting departmental and facility objectives
- Participate in facility Internal Audit programme
The successful candidate will possess;
- Relevant science / engineering degree
- Six Sigma qualified – minimally Green Belt level (desirable)
- Knowledge and understanding of applicable regulations especially with regards to Non Conformance, CAPA, Root Cause Analysis and Trending
- Class III medical device knowledge (desirable)
- Proven experience of working in a global company within a regulated industry, preferably medical device or pharmaceutical manufacturing
- Working knowledge of Minitab or similar statistical tool (desirable)
- Experience of FDA regulations
- Thorough knowledge of regulatory standards, Quality Management Systems and global regulations for medical devices
- Strong analytical and problem-solving skills, including appropriate use of statistical techniques
- Proven ability to manage and prioritise work load, meet deadlines and work in a pressurised environment
- Must be able to work cross-functionally and be able to lead teams CAPA / NCR Quality Engineers to complete appropriate CAPAs / NCRs to effective timely closure.
- Must be able to influence change with objective information and well-structured communications.
- Must be able to work cross-functionally and be able to lead teams Complaints quality Engineers and Investigators to complete appropriate complaints documentation for products and processes.
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Quality Engineer - NCR/CAPA in Renfrew employer: Terumo Aortic
Join a dynamic and innovative team as a Supply Planner, where your analytical skills will directly contribute to optimising our supply chain in a fast-paced environment. We pride ourselves on fostering a collaborative work culture that encourages continuous improvement and professional growth, offering you the opportunity to make a tangible impact on service levels and inventory performance. Located in a thriving area, we provide a supportive atmosphere with access to cutting-edge tools and resources, ensuring you have everything you need to succeed.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Engineer - NCR/CAPA in Renfrew
✨Tip Number 1
Network like a pro! Reach out to current employees at Terumo Aortic on LinkedIn or through mutual connections. A friendly chat can give you insider info and might just get your foot in the door.
✨Tip Number 2
Prepare for the interview by brushing up on your CAPA and NCR knowledge. Be ready to discuss real-life examples where you've successfully implemented corrective actions or conducted root cause analysis.
✨Tip Number 3
Show off your analytical skills! Bring along any relevant data trends or reports you've worked on in the past. This will demonstrate your ability to handle the responsibilities of the role effectively.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in joining the Terumo Aortic team.
We think you need these skills to ace Quality Engineer - NCR/CAPA in Renfrew
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Engineer role. Highlight your experience with NCR/CAPA processes and any relevant qualifications like Six Sigma. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality engineering and how you can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Your Problem-Solving Skills:In your application, don’t forget to mention specific examples of how you've tackled challenges in previous roles. We’re keen on seeing your analytical skills in action, especially when it comes to root cause analysis.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team at Terumo Aortic!
How to prepare for a job interview at Terumo Aortic
✨Know Your NCR/CAPA Inside Out
Make sure you brush up on your knowledge of Non-Conformance Reports (NCR) and Corrective and Preventive Actions (CAPA). Be ready to discuss specific examples from your past experience where you've successfully managed these processes. This will show that you not only understand the theory but also have practical skills.
✨Showcase Your Analytical Skills
Since the role requires strong analytical abilities, prepare to demonstrate how you've used statistical tools like Minitab in previous roles. Bring along examples of data trends you've analysed and how they influenced decision-making. This will highlight your problem-solving skills and your ability to work with data.
✨Communicate Effectively
Effective communication is key in this role, especially when collaborating with cross-functional teams. Practice articulating your thoughts clearly and concisely. You might even want to prepare a few scenarios where you successfully facilitated discussions or resolved conflicts to showcase your coordination skills.
✨Understand Regulatory Standards
Familiarise yourself with the relevant regulations and standards in the medical device industry, particularly those related to quality management systems. Be prepared to discuss how you've ensured compliance in your previous roles. This will demonstrate your commitment to maintaining high-quality standards in a regulated environment.
