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For Companies At a Glance
- Tasks: Lead quality engineering projects and solve complex problems in medical device environments.
- Company: Join a leading medical device company focused on innovation and quality.
- Benefits: Competitive hourly pay, professional development, and a collaborative work culture.
- Why this job: Make a real impact in healthcare by ensuring product quality and compliance.
- Qualifications: Bachelor’s or Master’s in Engineering with 6+ years in quality roles.
- Other info: Opportunity for career growth and to work with cutting-edge technology.
The predicted salary is between 48000 - 72000 £ per year.
Pay Range: $60.01/hr - $63.34/hr
Requirements
- Bachelor’s or Master’s degree in Engineering (Mechanical, Chemical, Biomedical, Bioengineering, or related applied sciences).
- Experience in medical device engineering or medical device quality roles.
- Experience with statistical software such as Minitab or JMP.
- Minimum 6 years of experience in medical device engineering or quality engineering.
Responsibilities
- Identify and solve complex problems in cross-functional environments while maintaining regulatory compliance.
- Manage cross-functional projects, timelines, and budgets.
- Implement digital quality tools including eQMS and dashboards.
- Translate technical information through presentations to all organizational levels.
- Independently lead QMS improvement activities and related projects.
- Own documentation changes and establish policies and standards.
- Lead CAPA execution, root cause investigations, and quality data analysis.
- Drive validation testing, TMV, and software validation activities.
- Lead manufacturing process development and optimization using Six Sigma and Lean tools.
- Identify and implement equipment, automation, and process improvements to reduce risk.
- Develop and execute complex experiments and validation protocols.
- Ensure completion of process validations (IQ/OQ/PQ), analyze results, and prepare reports.
Should Have
- Certified Quality Engineer (CQE) or equivalent.
- Process validation experience.
- Measurement and test equipment knowledge.
- Experience investigating manufacturing quality and compliance issues.
Skills
- Quality tools including FMEA, CAPA, and statistical analysis.
- Strong analytical and problem-solving abilities.
- Excellent communication and presentation skills.
- Ability to manage complex projects independently.
- Expertise in Quality Engineering principles.
Qualification and Education
- Bachelor’s or Master’s degree in Engineering or related applied sciences.
Principal Quality Engineer in Irvine employer: Cynet systems Inc
Contact Detail:
Cynet systems Inc Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Quality Engineer in Irvine
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the hunt for a Principal Quality Engineer role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge and problem-solving skills. Be ready to discuss your experience with quality tools like FMEA and CAPA, and how you've tackled complex projects in the past. We want to see you shine!
✨Tip Number 3
Showcase your leadership skills! When discussing your past roles, highlight instances where you led cross-functional teams or managed projects. This will demonstrate your ability to drive results and manage timelines effectively.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search. So, get that application in and let’s make it happen!
We think you need these skills to ace Principal Quality Engineer in Irvine
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in medical device engineering and quality roles. We want to see how your skills align with the requirements, so don’t be shy about showcasing your relevant projects and achievements!
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 your background makes you a perfect fit for the Principal Quality Engineer role. Keep it engaging and personal!
Showcase Your Technical Skills: Don’t forget to mention your experience with statistical software like Minitab or JMP. We love seeing candidates who can leverage these tools to drive quality improvements, so make sure to highlight any relevant projects or results.
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 the StudySmarter team!
How to prepare for a job interview at Cynet systems Inc
✨Know Your Stuff
Make sure you brush up on your engineering fundamentals, especially in medical devices. Be ready to discuss your experience with quality engineering principles and tools like FMEA and CAPA. This will show that you’re not just familiar with the concepts but can apply them effectively.
✨Showcase Your Problem-Solving Skills
Prepare examples of complex problems you've solved in cross-functional teams. Highlight your experience with statistical software like Minitab or JMP, and be ready to explain how you used these tools to drive quality improvements. Real-life examples will make your answers stand out.
✨Communicate Clearly
Since you'll need to translate technical information to various audiences, practice explaining your past projects in simple terms. Use clear, concise language and focus on the impact of your work. This will demonstrate your excellent communication skills and ability to lead presentations.
✨Be Project Savvy
Familiarise yourself with project management principles, especially regarding timelines and budgets. Be prepared to discuss how you've managed cross-functional projects in the past, including any challenges you faced and how you overcame them. This will show your capability to handle the responsibilities of the role.
