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- Tasks: Lead the Quality Management System and drive continuous improvement in global healthcare.
- Company: Join a dynamic team focused on making a real impact in healthcare.
- Benefits: Competitive salary, career growth, and the chance to work with regulatory agencies.
- Why this job: Be a key player in ensuring quality and compliance in innovative healthcare solutions.
- Qualifications: 7-10 years in Quality Assurance with proven leadership and regulatory experience.
- Other info: Exciting opportunity for personal and professional development in a regulated environment.
The predicted salary is between 55000 - 60000 £ per year.
This range is provided by X4 Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
Direct message the job poster from X4 Life Sciences
Job Title: Senior Manager, Quality Assurance
Location: Nottinghamshire, UK
Job Type: Permanent
Our client is seeking an accomplished Senior Quality Assurance Manager to join their team and take responsibility for the site Quality Management System. This is an exciting opportunity for a proven professional who thrives in highly regulated environments and wants to make a real impact on global healthcare. In this role, you’ll lead audits and inspections, guide cross-functional teams, and drive continuous improvement initiatives, all while ensuring compliance with international standards.
Key Responsibilities:
- Lead the site Quality Management System in compliance with ISO 13485, FDA, EU, UK MDR, and other applicable global regulations; serve as the site Quality Management Representative.
- Manage and develop the Quality Assurance team, overseeing audits, inspections, product registrations, certifications, and supplier quality activities.
- Drive continuous product and process improvements using data-driven methodologies (Six Sigma, Lean, DOE, FMEA, Gage R&R) and ensure effective nonconformance management and corrective actions.
- Support new product development and launches by ensuring quality, performance, and regulatory compliance, while also overseeing labeling, claims, and global regulatory submissions.
- Monitor evolving domestic and international regulations, provide proactive compliance strategies, and manage departmental budgets, performance reviews, and team development.
Experience and Qualifications Required:
- 7-10 years Quality Assurance experience
- Proven leadership skills with the ability to motivate teams, drive performance, and manage change through Lean and Six Sigma principles.
- Direct experience interacting with regulatory agencies (FDA, MHRA, Notified Bodies, and others), including leading audits, inspections, and securing licenses and registrations.
- Excellent communication skills (written and verbal), with the ability to collaborate across functions, manage large-scale projects, and work effectively in both in-person and virtual environments.
How to apply: Apply to e.smailes@x4lifesciences.com to learn more about the role or connect with me on LinkedIn to hear about regular job updates available with X4 Life Sciences.
Seniority level
- Mid-Senior level
Employment type
- Full-time
Job function
- Quality Assurance
- Industries: Medical Equipment Manufacturing
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Senior Quality Assurance Manager employer: X4 Life Sciences
Contact Detail:
X4 Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Assurance Manager
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work in quality assurance or healthcare. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485 and other relevant regulations. We want you to be able to showcase your expertise confidently, so practice answering questions about audits and compliance strategies.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. When you find a role that excites you, apply through our website to ensure your application gets the attention it deserves!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can set you apart from other candidates. It shows your enthusiasm for the role and keeps you fresh in the interviewer's mind.
We think you need these skills to ace Senior Quality Assurance Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Quality Assurance Manager role. Highlight your experience with ISO 13485, FDA, and other relevant regulations. We want to see how your background aligns with the responsibilities listed in the job description.
Showcase Leadership Skills: Since this role involves managing a team, don’t forget to showcase your leadership skills. Share examples of how you've motivated teams and driven performance improvements using Lean and Six Sigma principles. We love seeing real-life impacts!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality assurance in healthcare and how you can make a difference at our company. Keep it engaging and relevant to the role we’re offering.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any updates. Let’s get your journey started!
How to prepare for a job interview at X4 Life Sciences
✨Know Your Regulations
Make sure you brush up on ISO 13485, FDA, and UK MDR regulations before the interview. Being able to discuss these standards confidently will show that you’re not just familiar with them but can also apply them in real-world scenarios.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led teams and driven performance improvements. Use specific metrics or outcomes to illustrate your impact, especially in a regulated environment. This will demonstrate your capability to manage and motivate a team effectively.
✨Be Data-Driven
Familiarise yourself with methodologies like Six Sigma and Lean. Be ready to discuss how you've used data to drive continuous improvement initiatives in past roles. This will highlight your analytical skills and commitment to quality assurance.
✨Practice Your Communication
Since excellent communication is key for this role, practice articulating your thoughts clearly and concisely. Consider doing mock interviews with a friend or mentor to refine your verbal and written communication skills, ensuring you can collaborate effectively across functions.
