Job Description

The QMS & Document Specialist Manager will be responsible for overseeing and maintaining our Quality Management System, ensuring compliance with medical device regulations and standards. The ideal candidate will have direct experience managing paper-based QMS, with the ability to transition to an electronic QMS (eQMS) in the coming year. This role requires expertise in document control, internal/external auditing, and quality compliance, with a strong background in the medical device startup environment. Key Responsibilities: Oversee and manage the company’s paper-based QMS, ensuring compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulations. Lead the transition from a paper-based QMS to an electronic QMS, ensuring a smooth and compliant implementation. Develop, maintain, and improve document control procedures, ensuring document integrity, version control, and accessibility. Plan and conduct internal and external audits, ensuring compliance with regulatory standards and company policies. Act as the primary point of contact for regulatory and certification audits, assisting with audit readiness and responses. Support cross-functional teams in developing and maintaining quality documentation, procedures, and records. Train and mentor employees on QMS processes, document control, and quality requirements. Identify and implement process improvements to enhance efficiency and compliance. Work closely with regulatory and quality teams to support product development, manufacturing, and post-market activities. Qualifications & Experience: ~ B.S in Mechanical Engineering, Biomedical Engineering, Electrical Engineering or related discipline ~5+ years of experience in the medical device industry, with a strong focus on QMS, document control, and auditing. ~ Previous experience in a startup environment and an understanding of the challenges and fast-paced nature of startups. ~ Proven experience managing a paper-based QMS and leading the transition to an electronic QMS. ~ Strong knowledge of ISO 13485, FDA 21 CFR Part 820, MDR, and other medical device regulatory requirements. ~ Experience conducting internal and external audits, including supplier audits. ~ Excellent organizational, analytical, and problem-solving skills. ~ Ability to work independently and collaboratively in a dynamic environment. ~ Strong communication and training skills, with the ability to guide teams through compliance and documentation requirements. ~ Experience with eQMS platforms (preferred, but not required).

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