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- Tasks: Lead and enhance the global Quality Management System in a fast-paced medical device environment.
- Company: Dynamic medical device company focused on innovation and quality.
- Benefits: Competitive salary, leadership opportunities, and a chance to shape quality culture.
- Why this job: Make a real impact on healthcare by ensuring product quality and compliance.
- Qualifications: 10+ years in medical device quality roles and strong regulatory knowledge.
- Other info: Join a collaborative leadership team and drive quality in a growth-stage company.
The predicted salary is between 72000 - 108000 £ per year.
The Senior Director QA is the senior leader accountable for the company’s global Quality Management System (QMS) and overall quality performance. This role sets the quality strategy and ensures effective execution across design, manufacturing, clinical, and commercial activities in a highly regulated, growth-stage medical device environment.
Operating at both strategic and hands-on levels, the Senior Director QA ensures the QMS is robust, scalable, and inspection-ready at all times, while enabling the business to grow at pace. The role provides clear leadership, sound judgement, and pragmatic decision-making to balance regulatory compliance with operational delivery.
Reporting to the COO, the Senior Director QA is a key member of the leadership team, acting as a trusted partner to Regulatory, R&D, Clinical, Operations, Supply Chain, and Commercial functions, with global responsibility across the U.S., EU, and other markets.
Key Responsibilities:- Own and continuously improve the global Quality Management System in compliance with ISO 13485.
- Ensure a sustained state of inspection readiness for FDA, Notified Bodies, and other regulators.
- Lead Management Review, internal audit programs, and quality performance metrics.
- Proactively identify and mitigate quality-related business risks.
- Partner closely with Regulatory Affairs on submissions, changes, and post-market obligations.
- Ensure compliance with FDA QSR / 21 CFR 820, EU MDR, MDSAP, and other applicable global regulations.
- Own responses to regulatory inspections, audits, observations, and findings.
- Oversee supplier qualification, audits, and ongoing performance management.
- Ensure effective systems for CAPA, nonconformances, complaints, and change control.
- Support manufacturing scale-up while maintaining regulatory compliance and product quality.
- Build, lead, and develop the Quality organization as the company scales.
- Set clear expectations, accountability, and development pathways for quality managers and teams.
- Drive a quality culture that balances compliance, speed, and pragmatism.
- Serve as a credible, trusted partner to cross-functional and executive stakeholders.
- Science or Engineering degree (or equivalent).
- 10+ years’ experience in medical device quality roles within regulated environments.
- Prior experience as Head of Quality, Senior Director, or equivalent senior quality leadership role.
- Deep working knowledge of FDA QSR / 21 CFR 820, ISO 13485, ISO 14971, and EU MDR.
- Proven experience leading regulatory inspections and audits (FDA and/or Notified Body).
- Strong expertise across CAPA, supplier quality, complaints, and design controls.
- Demonstrated ability to operate hands-on in a growth-stage organization.
- Track record of scaling quality systems in startup or mid-sized medical device companies.
- Experience in Class II / Class III, active or implantable medical devices.
- Experience in neuromodulation or complex electro-mechanical devices.
- Experience supporting global commercial expansion.
- Experience with MDSAP.
- Practical, business-minded approach to quality and compliance.
- High integrity with strong judgement and decision-making capability.
- Able to influence and lead without unnecessary bureaucracy.
- Comfortable making decisions with incomplete information.
- Clear, confident communicator with executive presence.
Senior Director of Quality Assurance in Bolton employer: Phagenesis
Contact Detail:
Phagenesis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Director of Quality Assurance in Bolton
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the hunt for a Senior Director of Quality Assurance role. You never know who might have the inside scoop on an opening or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485 and FDA regulations. Be ready to discuss how you've successfully led quality systems in the past, and don't forget to highlight your hands-on experience in growth-stage environments.
✨Tip Number 3
Showcase your leadership skills! During interviews, share examples of how you've built and developed quality teams. Emphasise your ability to create a quality culture that balances compliance with speed—this is key for a role like this.
✨Tip Number 4
Don't just apply anywhere—apply through our website! We want to see your application and get to know you better. Tailor your CV and cover letter to reflect your experience in regulatory compliance and quality management, and make sure to highlight your strategic thinking.
We think you need these skills to ace Senior Director of Quality Assurance in Bolton
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Director of Quality Assurance role. Highlight your experience in quality management systems and regulatory compliance, especially in medical devices. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of your leadership in quality assurance and how you've successfully navigated regulatory challenges. We love a good story that showcases your skills!
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use metrics and outcomes to demonstrate how you’ve improved quality systems or led successful audits. We’re looking for results-driven candidates who can make an impact.
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 any important updates. Plus, it’s super easy!
How to prepare for a job interview at Phagenesis
✨Know Your Quality Management Systems
Make sure you brush up on your knowledge of ISO 13485 and FDA QSR / 21 CFR 820. Be ready to discuss how you've implemented or improved quality management systems in your previous roles, as this will show your hands-on experience and strategic thinking.
✨Showcase Your Leadership Skills
Prepare examples that highlight your leadership style and how you've built and developed quality teams. Discuss how you've fostered a quality culture in past positions, as this role requires strong people management skills.
✨Be Ready for Regulatory Discussions
Expect questions about your experience with regulatory inspections and audits. Have specific examples ready that demonstrate your ability to navigate complex regulatory environments and how you've successfully managed compliance challenges.
✨Demonstrate Your Business Acumen
This role is not just about quality; it's about balancing compliance with operational delivery. Prepare to discuss how you've made pragmatic decisions that support business growth while maintaining high-quality standards.
