Medical Device QA/RA Manager
About the role
Competitive Salary + Equity Options + Benefits
QV Bioelectronics is seeking an experienced Quality Manager to join our team on a permanent basis. The post holder will focus on the institution and implementation of an ISO13485 quality management system. The candidate should have an interest in start-ups and emerging technology and will support the regulatory and quality management requirements for market approval of an innovative class III medical device. Our approach combines the cutting edge of biology, advanced materials and precision engineering.
We are a rapidly growing company with a small, passionate team with a range of scientific backgrounds. This is a rare opportunity to join an early-stage but rapidly growing MedTech company at a senior level and to share in our success as we grow. As a member of our team, you will be responsible for making decisions that have an enormous impact on the future of our business from day one and be expected to lead quality management programs with significant autonomy, you will also be expected to contribute to our wider regulatory strategy and other aspects of technology development.
You will work closely alongside our technical and clinical team members and also our numerous sub-contractors and collaborators. You will also work alongside our highly experienced external Quality Consultant, who will be able to provide mentorship, technical training and support in implementing our ISO 13485 quality management system.
Responsibilities would include:
• Implement/monitor processes and procedures to ensure the companies QA
measures align with regulatory standards
• Manage the company’s quality management systems for ISO 13485 including
third party external audits, such as preparation of relevant QMS documents.
• Take the lead role in the assembly of our Technical File for submission to
healthcare regulatory agencies internationally.
• Provide guidelines, support and training to staff in the operation of quality
assurance and control methods to ensure that the companies policies and up
to date and meet the requirements of international regulators
• Manage the quality management systems and facilitate internal audits to
ensure effective quality control procedures are implemented and are
• Work closely with the technical and production team to improve production
processes and quality control, in order to obtain CE mark
• Act as senior point of contact for compliance issues and instigate corrective
action internally and externally when non- conforming issues arise
• Support the activities involved in the regulatory management of post market
surveillance and vigilance activities in compliance with the MDD.
Successful candidates would:
• Hold a BSc or Masters degree in life sciences, engineering or related
• Have 3+ years of experience of operating within an ISO13485 QM system in a
MedTech, pharmaceutical or biotech company.
• Have experience in internal and external quality auditing
• Have an ambition to step up in the future and take the lead in all aspects of the
company’s quality management and regulatory affairs activity.
• Have a rigorous approach to work with a strong eye for detail
• Have strong communication, interpretation and presentation abilities
• Be passionate about technology, healthcare and entrepreneurship
• Be an excellent written and oral communicator
• Be driven, motivated and organised
• Be a team player with demonstrable leadership potential
• Be a quick learner willing to throw themselves into new challenges
Alderley Edge, England, United Kingdom