Sr. Director Quality
Position Summary
We are seeking an experienced Senior Director of Quality to provide strategic leadership across quality systems, compliance, and operational excellence initiatives within a growing medical device organization. This individual will partner closely with cross-functional teams to ensure product quality, regulatory compliance, and continuous improvement throughout the product lifecycle.
The Senior Director of Quality will be responsible for leading quality programs, supporting manufacturing and product development activities, and fostering a culture of quality across the organization.
Key Responsibilities
- Provide leadership and oversight for company-wide quality systems and compliance activities.
- Drive continuous improvement initiatives focused on product quality, operational performance, and customer satisfaction.
- Partner with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and Operations teams to support business objectives and product lifecycle management.
- Ensure compliance with applicable regulatory requirements, industry standards, and company procedures.
- Lead internal and external audit activities, inspections, and quality-related assessments.
- Oversee quality metrics, management review activities, and strategic quality planning.
- Support risk management, CAPA, complaint handling, nonconformance, and change control processes.
- Develop and mentor high-performing quality teams while building organizational capability.
- Collaborate with executive leadership on quality strategy, resource planning, and business initiatives.
- Promote a culture of accountability, compliance, and continuous improvement.
Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline; advanced degree preferred.
- Progressive quality leadership experience within the medical device, life sciences, or highly regulated industry.
- Strong knowledge of quality management systems, regulatory requirements, and industry best practices.
- Experience leading teams and influencing stakeholders across multiple functions and organizational levels.
- Demonstrated success managing complex projects, driving improvements, and supporting organizational growth.
- Excellent communication, leadership, and problem-solving skills.
Preferred Experience
- Experience supporting manufacturing, product development, or commercialized products.
- Knowledge of domestic and international quality and regulatory requirements.
- Background leading audits, inspections, and compliance initiatives.
- Track record of developing and implementing scalable quality processes in a regulated environment.
What We Offer
- Opportunity to influence quality strategy and organizational performance.
- Collaborative and mission-driven environment.
- Competitive compensation and comprehensive benefits package.
- Professional growth and leadership development opportunities.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.