Manager - Quality Engineering
Job Summary:
We are seeking an experienced and strategic Manager of Quality Engineering to lead a team of quality professionals supporting product development, manufacturing, and regulatory compliance. This individual will play a key role in ensuring product quality and process integrity throughout the lifecycle.
Key Responsibilities:
Lead and mentor a team of quality engineers focused on product design, manufacturing, and quality system support.
Oversee the application of quality engineering principles, including risk management, process validation, and design controls.
Ensure compliance with applicable regulatory and quality standards, such as FDA QSR, ISO 13485, and EU MDR.
Collaborate cross-functionally with R&D, operations, regulatory, and manufacturing teams to drive quality initiatives.
Manage quality engineering activities for CAPA, nonconformances, complaints, and continuous improvement.
Support internal and external audits, and contribute to regulatory submissions.
Provide input into long-term quality strategy, resource planning, and system improvements.
Qualifications:
Bachelor's degree in Engineering, Life Sciences, or related technical discipline (advanced degree preferred).
Minimum of 7 years of experience in the medical device industry, with at least 2 years in a leadership capacity.
Strong knowledge of quality engineering practices, product lifecycle management, and risk-based decision-making.
Experience with Class II or III medical devices is highly desirable.
Excellent leadership, problem-solving, and communication skills.
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 CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, 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 CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.