Job Description
About the Role:
We are seeking a highly skilled and motivated Quality Assurance Team Lead to oversee and support the operation of a comprehensive Quality Management System (QMS) in a dynamic medical device environment. As part of our team, you will drive the development, implementation, and continuous improvement of quality processes while ensuring compliance with ISO13485, 21 CFR Part 820, and other regulatory requirements. This is an exciting opportunity to play a key role in a rapidly growing field, making a real impact on healthcare access and innovation.
Key Responsibilities:
* Lead and support the implementation of QMS processes to ensure quality standards are met.
* Manage, mentor, and assign tasks to the QA team to ensure efficient workload distribution.
* Serve as the system administrator for the eQMS system (QT9), ensuring all processes are documented and compliant.
* Train employees across departments on QMS procedures and best practices.
* Audit internal processes and procedures to ensure ongoing compliance and effectiveness.
* Collaborate with cross-functional teams to implement quality improvements and operational efficiencies.
* Monitor key performance indicators (KPIs) and work to improve performance metrics.
* Provide guidance and support to staff in executing QMS processes across departments.
* Develop controlled documents (e.g., SOPs) and maintain regulatory compliance.
* Support the maintenance and evolution of the company’s QMS in line with industry standards.
Qualifications:
* Education: BSc in a relevant scientific discipline or equivalent experience.
* Experience:At least 5 years of hands-on experience in the development, operation, and maintenance of ISO13485-compliant QMS.
* Minimum of 2 years of experience in the IVD or medical device industry.
* Skills:Strong understanding of ISO13485, 21 CFR Part 820, and IVD Directive (98/79/EC).
* Ability to create and maintain controlled documents like SOPs.
* Proficiency in operating electronic QMS systems, including document control.
* Strong communication and interpersonal skills, with experience collaborating in cross-functional teams.
* Experience in process-based auditing and compliance monitoring.
* Knowledge of ISO14971 and software validation (either as a stand-alone medical device or incorporated into a device).
* Ability to train and mentor others effectively.
* Exceptional attention to detail and ability to work under deadlines.
Why Join Us?
* Impactful Work: Join a fast-paced and innovative company dedicated to improving access to healthcare through cutting-edge technology.
* Career Growth: Gain exposure to a variety of cross-functional teams and regulatory requirements, expanding your knowledge and skill set.
* Inclusive Environment: We pride ourselves on fostering a diverse and inclusive workplace where all employees feel valued and empowered.
* Collaborative Culture: Work alongside passionate professionals committed to making a difference in the healthcare industry.
Equal Opportunity Employer:
We encourage applicants from diverse backgrounds, including people of color, LGBTQIA+ individuals, disabled candidates, and veterans. We are committed to creating an inclusive environment where everyone has the opportunity to thrive.
Interested?
If you are an experienced QA professional passionate about improving healthcare and ensuring quality in the medical device industry, we’d love to hear from you. Apply today to join a mission-driven team making a real difference in the world.