At a Glance
- Tasks: Lead quality assurance for medical devices, ensuring safety and compliance.
- Company: Spacelabs Healthcare, innovating healthcare through technology.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Join a dynamic team focused on continuous improvement and operational excellence.
- Why this job: Make a real difference in patient safety and healthcare innovation.
- Qualifications: Bachelor’s degree and 7+ years in Quality or Engineering roles required.
The predicted salary is between 48000 - 72000 £ per year.
At Spacelabs Healthcare, we’re committed to transforming healthcare through continuous innovation. Our scalable solutions deliver critical patient data across local and remote systems, empowering better decisions, improving efficiency, and enhancing patient safety.
We’re seeking a Senior Quality Assurance Engineer to lead and support Quality Management System (QMS) performance across design, manufacturing, service, and compliance functions. This role is pivotal in ensuring our medical devices are safe, effective, and compliant with global standards.
Responsibilities
- Design Control & Product Development
- Mentor design teams on Design Controls, Risk Management, and Electrical Safety.
- Review Engineering Change Orders for sound engineering practices and compliance.
- Support technical documentation including Essential Requirements Checklists and Risk Management Files.
- Collaborate with engineering on regulatory submissions and design planning.
- Manufacturing & Process Improvement
- Oversee manufacturing processes, work instructions, and inspection protocols.
- Approve Device History Records to ensure compliance with Device Master Record requirements.
- Conduct 7S-based floor walkthroughs to drive operational improvements.
- Post-Market Surveillance & Service
- Monitor product performance and service documentation.
- Escalate and address defects, assess trends, and identify improvement opportunities.
- Quality System Administration
- Lead internal audits, CAPA, process change control, and supplier quality activities.
- Maintain compliance with ISO 13485, MDR/MDD, MDSAP, and other global standards.
- Support regulatory filings including 510(k), CE Mark, and IDE submissions.
- Material Review Board (MRB)
- Facilitate efficient processing of Nonconforming Material Reports and Rework Orders.
- Track and report MRB metrics to minimize backlog and improve throughput.
Qualifications
- Bachelor’s degree in Engineering, Quality, or related field (e.g., Biomedical, Electrical, Software).
- 7+ years in Quality or Engineering roles.
- 5+ years in medical device regulatory and QMS environments.
- Experience with SaMD or embedded software in medical devices.
- Strong knowledge of technical documentation and change control.
- Proficient in statistical analysis and risk-based QMS activities.
- Excellent communication skills and a proactive, organized approach.
Senior Quality Assurance Engineer employer: Rapiscan Systems Inc.
At Spacelabs Healthcare, we pride ourselves on being an exceptional employer dedicated to innovation in the healthcare sector. Our collaborative work culture fosters professional growth and development, offering employees opportunities to mentor and lead within a supportive environment. Located in a vibrant area, we provide competitive benefits and a commitment to employee well-being, making us an ideal choice for those seeking meaningful and rewarding careers in quality assurance.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Quality Assurance Engineer
✨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 refer you directly.
✨Tip Number 2
Prepare for interviews by practising common questions and scenarios related to Quality Assurance. Think about how your experience aligns with the role at Spacelabs Healthcare and be ready to share specific examples.
✨Tip Number 3
Showcase your passion for quality and safety in healthcare during interviews. Talk about your previous projects and how they improved processes or compliance. This will help you stand out as a candidate who truly cares.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at Spacelabs Healthcare.
We think you need these skills to ace Senior Quality Assurance Engineer
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Quality Assurance Engineer role. Highlight your experience in quality management systems and any relevant projects you've worked on. We want to see how your skills align with our mission at Spacelabs Healthcare!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about transforming healthcare and how your background makes you a perfect fit for this role. We love seeing genuine enthusiasm, so let your personality come through!
Showcase Relevant Experience:When detailing your work history, focus on your experience with medical devices and regulatory compliance. Mention specific achievements or improvements you've made in past roles that relate to the responsibilities listed in the job description. We appreciate concrete examples!
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 proactive and keen to join our team at Spacelabs Healthcare!
How to prepare for a job interview at Rapiscan Systems Inc.
✨Know Your Stuff
Make sure you brush up on your knowledge of Quality Management Systems and the specific regulations like ISO 13485 and MDR. Familiarise yourself with the latest trends in medical device quality assurance, as this will show your passion and commitment to the field.
✨Showcase Your Experience
Prepare to discuss your past experiences in detail, especially those related to design controls and risk management. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it easier for the interviewers to see how your background aligns with their needs.
✨Ask Smart Questions
Come prepared with insightful questions about their current projects or challenges they face in quality assurance. This not only shows your interest in the role but also gives you a chance to demonstrate your knowledge and critical thinking skills.
✨Be Proactive and Organised
Exhibit your proactive nature by discussing how you've led audits or improved processes in previous roles. Highlight your organisational skills by mentioning any tools or methods you use to keep track of compliance and documentation, which is crucial in this line of work.
