Overview:
We are seeking a seasoned Quality Manager to lead our remote quality assurance team in ensuring the highest standards of quality and compliance for our medical device products. This role will be responsible for overseeing quality processes, driving continuous improvement initiatives, and ensuring adherence to regulatory standards, all while managing a distributed team.
Responsibilities:
Lead and manage a remote team of quality assurance professionals, providing guidance, support, and mentorship to ensure the team’s effectiveness and growth.
Develop, implement, and maintain quality management systems (QMS) to meet regulatory requirements (e.g., FDA, ISO standards) for remote medical device manufacturing.
Collaborate with cross-functional teams to establish and enforce quality standards throughout the product development lifecycle, from design to manufacturing and distribution.
Conduct audits, both remote and on-site as necessary, to ensure compliance with quality standards and regulatory requirements.
Drive the development and execution of comprehensive test plans and protocols for remote testing, ensuring product performance, reliability, and safety.
Identify areas for process improvement and implement strategies to enhance quality assurance methodologies for a distributed workforce.
Stay updated with industry regulations and best practices in remote quality management within the medical device field.
Requirements:
Bachelor’s degree in Engineering or a related field; advanced degree preferred.
3+ years of progressive experience in quality management, preferably in the medical device industry.
Expertise in quality management systems and regulatory standards applicable to medical device manufacturing.
Proven leadership skills in managing remote teams, fostering collaboration, and achieving team objectives.
Strong analytical and problem-solving skills with a data-driven approach to decision-making.
Excellent communication and interpersonal skills to effectively liaise with remote teams and cross-functional stakeholders.
Benefits:
Competitive remote work compensation package.
Opportunities for professional development and career advancement.
Flexibility to work remotely, promoting work-life balance.
A collaborative and supportive team environment focused on innovation.
Health and wellness programs.