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- Tasks: Lead quality assurance efforts and mentor design teams in a dynamic healthcare environment.
- Company: Join Spacelabs Healthcare, a leader in innovative healthcare solutions.
- Benefits: Enjoy competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real difference in patient safety and healthcare innovation.
- Qualifications: 7+ years in Quality or Engineering roles with a focus on medical devices.
- Other info: Collaborative culture with a commitment to continuous improvement and compliance.
The predicted salary is between 36000 - 60000 £ 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.
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: OSI Systems, Inc
Contact Detail:
OSI Systems, Inc Recruiting Team
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 your connections in the healthcare and engineering sectors. Attend industry events or webinars where you can meet potential employers and showcase your expertise in quality assurance.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO standards and regulatory submissions. We recommend practising common interview questions related to quality management systems and risk management to show you're the right fit for the role.
✨Tip Number 3
Don’t just wait for job openings to pop up! Keep an eye on our website and apply directly through it. This way, you’ll be among the first to know about new opportunities that match your skills.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Mention something specific from your conversation to remind them why you’re the perfect candidate for their Senior Quality Assurance Engineer position.
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 and engineering roles, especially in medical device regulatory environments. We want to see how your skills align with our mission at Spacelabs Healthcare!
Showcase Relevant Experience: When writing your application, focus on showcasing your relevant experience, particularly in Design Controls, Risk Management, and compliance. Use specific examples that demonstrate your expertise and how you've contributed to operational improvements in past roles.
Be Clear and Concise: Keep your application clear and concise. Avoid jargon unless it's relevant to the role. We appreciate straightforward communication, so make it easy for us to see why you're a great fit for the team!
Apply Through Our Website: Don’t forget to apply 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 innovative team at Spacelabs Healthcare!
How to prepare for a job interview at OSI Systems, Inc
✨Know Your Stuff
Make sure you brush up on your knowledge of quality assurance processes, especially in the medical device sector. Familiarise yourself with ISO 13485 and other relevant regulations, as well as the specifics of risk management and design controls. This will show that you're not just a candidate, but a knowledgeable professional ready to contribute.
✨Showcase Your Experience
Prepare to discuss your past experiences in detail, particularly those that relate to the responsibilities listed in the job description. Think about specific projects where you mentored teams or improved processes. Use the STAR method (Situation, Task, Action, Result) to structure your answers and make them impactful.
✨Ask Smart Questions
Interviews are a two-way street, so come armed with insightful questions about the company's approach to quality assurance and their current challenges. This not only shows your interest but also your proactive mindset. For example, ask about their recent initiatives in post-market surveillance or how they handle compliance with changing regulations.
✨Demonstrate Communication Skills
Since excellent communication is key for this role, practice articulating your thoughts clearly and confidently. You might be asked to explain complex concepts, so think about how you can simplify technical jargon. Being able to communicate effectively with both technical and non-technical stakeholders will set you apart.
