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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 Manchester employer: Phagenesis
Contact Detail:
Phagenesis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Director of Quality Assurance in Manchester
✨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 opportunity or can put in a good word for you.
✨Tip Number 2
Prepare for those interviews by brushing up on your knowledge of ISO 13485 and FDA regulations. Be ready to discuss how you've led quality systems in the past and how you can bring that experience to the table. Confidence is key!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and expertise. Use our website to find roles that excite you, and tailor your approach to show how you can help them scale their quality systems effectively.
✨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 fit for their Senior Director QA position.
We think you need these skills to ace Senior Director of Quality Assurance in Manchester
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, as these are key for us. Use specific examples that showcase your leadership skills and hands-on experience in a growth-stage environment.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for our team. Mention your deep knowledge of FDA regulations and your track record in leading successful audits. Keep it engaging and personal – we want to see your passion for quality assurance!
Showcase Your Leadership Style: As a senior leader, we’re looking for someone who can inspire and develop teams. In your application, share examples of how you've built a quality culture and led cross-functional teams. We want to know how you balance compliance with operational delivery while keeping everyone motivated.
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 serious about joining our team at StudySmarter. We can’t wait to hear from you!
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
As a Senior Director, you'll need to demonstrate your ability to lead teams effectively. Prepare examples of how you've built and developed quality organisations in the past, and be ready to discuss how you foster a quality culture that balances compliance with operational speed.
✨Prepare for Regulatory Discussions
Expect questions about your experience with regulatory inspections and audits. Have specific examples ready that highlight your role in leading these processes, particularly with the FDA or Notified Bodies, to showcase your expertise in navigating complex regulatory environments.
✨Communicate Clearly and Confidently
Your communication skills will be under scrutiny, so practice articulating your thoughts clearly and confidently. Think about how you can convey complex quality concepts in a straightforward manner, as this will reflect your ability to influence and lead across various functions.
