At a Glance
- Tasks: Lead quality assurance processes and implement effective control systems for medical devices.
- Company: Join a leading Medical Device and Healthcare company in Plymouth, MN.
- Benefits: Enjoy health benefits, a referral program, and excellent growth opportunities.
- Why this job: Make a real impact on product quality and patient safety in healthcare.
- Qualifications: 3-5 years of experience and a relevant degree required.
- Other info: Be part of an inclusive workplace that values diversity and collaboration.
The predicted salary is between 28800 - 48000 £ per year.
Our Client, a Medical Device and Healthcare company, is looking for a Quality Engineer II for their Plymouth, MN location.
Responsibilities
- Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
- Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
- Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Design and conduct experiments for process optimization and/or improvement.
- Appropriately document experiment plans and results, including protocol writing and reports.
- Lead process control and monitoring of CTQ parameters and specifications.
- Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
- Lead the investigation, resolution and prevention of product and process non-conformances.
- Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
- Lead in the completion and maintenance of risk analysis.
- Work with design engineering in the completion of product verification and validation.
- Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Requirements
- 3-5 years experience.
- Degree Required.
Why Should You Apply?
- Health Benefits.
- Referral Program.
- Excellent growth and advancement opportunities.
Quality Engineer II in Plymouth employer: ICONMA
Contact Detail:
ICONMA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineer II in Plymouth
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend meetups, and connect with people on LinkedIn. 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 practising common questions and showcasing your problem-solving skills. Think about how you can apply methodologies like Six Sigma and Lean Manufacturing in real scenarios – that’ll impress them!
✨Tip Number 3
Don’t just wait for job postings; be proactive! Research companies you admire and reach out directly. Express your interest in their quality engineering roles and show them how you can add value.
✨Tip Number 4
Finally, apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are genuinely interested in joining our team.
We think you need these skills to ace Quality Engineer II in Plymouth
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Engineer II role. Highlight relevant experience and skills that match the job description, like process control systems and problem-solving methodologies. We want to see how you can contribute to our team!
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 aligns with our needs. We love seeing enthusiasm and a personal touch in applications.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use specific examples of how you've implemented process improvements or resolved quality issues. This helps us understand the impact you've made in previous roles.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to keep track of your application status. Plus, we love seeing candidates who take the initiative!
How to prepare for a job interview at ICONMA
✨Know Your Quality Standards
Familiarise yourself with the relevant quality standards and regulations, especially those related to medical devices and healthcare. Understanding FDA regulations and how they apply to the role will show your commitment and readiness to meet compliance requirements.
✨Showcase Problem-Solving Skills
Prepare examples of how you've applied systematic problem-solving methodologies in past roles. Be ready to discuss specific instances where you identified and resolved quality issues, as this is crucial for a Quality Engineer II position.
✨Demonstrate Process Improvement Knowledge
Brush up on Six Sigma and Lean Manufacturing principles. Be prepared to discuss how you've led or participated in process improvement initiatives, and think of ways you can apply these methodologies in the new role.
✨Engage with Team Dynamics
Highlight your experience working collaboratively with cross-functional teams, especially in quality disciplines. Be ready to share how you’ve contributed to team success and how you can bring that collaborative spirit to their organisation.