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For Companies At a Glance
- Tasks: Ensure quality compliance and optimise management systems for medical devices.
- Company: Join a leading medical technology company focused on quality and innovation.
- Benefits: Competitive salary, remote work options, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare by ensuring product quality and compliance.
- Qualifications: Bachelor’s or Master’s in Science, Quality, or Engineering; 5 years QA experience preferred.
- Other info: Collaborative environment with strong focus on continuous improvement and career advancement.
The predicted salary is between 36000 - 60000 £ per year.
We are looking for our future QA - Engineer to join our Quality Assurance team in GB.
Let's talk about the role:
The primary role of Quality Assurance function is to ensure that management systems are established to enable business compliance, multiple regulatory frameworks and to support the design, development and manufacture of products which meet our customer’s quality requirements. The management, maintenance, and optimisation of the structure and integrity of the Global Quality Management Systems (QMS) to ensure ResMed’s products and operations comply with the regulatory requirements applicable to medical devices for the markets in which they are distributed.
Let's talk about key responsibilities:
- Support to ensure all aspects of the ResMed UK & South Africa (ZA) Quality Management Systems (QMS) are compliant and aligned with:
- Applicable regulatory standards/requirements
- Business requirements
- As well as other ResMed QMS entities when applicable.
- Ensure the implementation of the actions, procedures, and processes necessary for the compliance of the Quality activities with the ResMed quality policy and the UK & ZA regulations in force, to achieve quality objectives.
- Proactively contribute to reviewing, analysing, and implementing opportunities for continual improvement of the QMS, quality documents and records in UK & ZA.
- Reporting to management any obstacles or potential hazards, that may impact on the effectiveness of the quality management system; and identify any need for improvement.
- Support Global and Regional ResMed teams as appropriate to ensure compliance to applicable regulation and ResMed standard procedures.
Let's talk about qualifications and experience:
- Bachelor’s degree or Master in Science, Quality or Engineering.
- Minimum 5 years applied professional quality assurance experience ideally including the medical industry.
- Experience with CAPA and Audits.
- Strong planning and organization skills.
- Strong listening, verbal, and written communication skills.
- Ability to work remotely and effectively with remote teams, building and maintaining positive relationships while influencing change.
- Ability to collaborate at different functions such as business, distribution chain partners, Regulatory affairs team, ResMed Manufacturer team, operational, commercial and marketing teams.
- Knowledge of EU MDR 2017/745.
- Experience in the maintenance of Management Systems including ongoing improvement of systems and processes.
- Project management experience.
- Ability to think clearly and critically, assess information and evidence to make informed, timely decisions.
- Act as a role model for others within QA and the broader business.
QA Specialist employer: ResMed Inc
Contact Detail:
ResMed Inc Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Specialist
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those already working at ResMed. A friendly chat can open doors and give you insider info on what they’re really looking for.
✨Tip Number 2
Prepare for interviews by practising common QA scenarios. Think about how you’d handle compliance issues or improve quality systems. We want to see your problem-solving skills in action!
✨Tip Number 3
Show off your passion for quality assurance! Share examples of how you’ve contributed to quality improvements in past roles. This will help us see how you can add value to our team.
✨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 take that extra step to connect with us directly.
We think you need these skills to ace QA Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the QA Specialist role. Highlight your experience in quality assurance, especially in the medical industry, and showcase any relevant qualifications. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and how you can contribute to our team. Be sure to mention your experience with CAPA and audits, as these are key for us.
Showcase Your Communication Skills: Since strong communication is vital for this role, make sure your written application reflects that. Use clear and concise language, and don’t forget to proofread for any typos or errors. We appreciate attention to detail!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at ResMed Inc
✨Know Your QMS Inside Out
Make sure you’re well-versed in Quality Management Systems, especially those relevant to the medical industry. Brush up on EU MDR 2017/745 and be ready to discuss how you’ve implemented or improved QMS processes in your previous roles.
✨Showcase Your Audit Experience
Prepare specific examples of your experience with CAPA and audits. Be ready to explain how you’ve handled audit findings and what steps you took to ensure compliance. This will demonstrate your hands-on experience and problem-solving skills.
✨Highlight Your Collaboration Skills
Since building positive relationships is key, think of instances where you’ve successfully collaborated with cross-functional teams. Share how you influenced change and contributed to team success, especially in a remote working environment.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your critical thinking and decision-making abilities. Practice articulating your thought process when faced with quality challenges, and how you would approach continual improvement within a QMS.
