Overview:
EPM is hiring on behalf of a leading medical device manufacturer recognized for its innovation and excellence in producing active medical devices and software solutions. This hybrid position offers a unique opportunity to play a pivotal role in ensuring the quality and compliance of cutting-edge products that advance healthcare worldwide.
Key Responsibilities:
- Oversee and enhance quality assurance processes for active medical devices and associated software, ensuring compliance with FDA, ISO 13485, IEC 62304, and other applicable global standards.
- Participate in product lifecycle activities, including design verification, validation, and risk management, to ensure quality integration from concept to post-market.
- Lead root cause analysis, non-conformance investigations, and corrective and preventive action (CAPA) activities.
- Collaborate cross-functionally with R&D, manufacturing, and regulatory teams to ensure adherence to quality standards throughout development and production.
- Conduct and support internal and external audits, including supplier audits, ensuring robust documentation and adherence to applicable regulations.
- Provide quality input for software lifecycle management, including configuration control, validation, and cybersecurity compliance.
- Stay updated on industry trends, emerging regulations, and best practices to guide continuous improvement initiatives.
- Mentor and train junior QA staff on best practices, standards, and regulatory requirements.
Qualifications:
- Bachelor's degree in Engineering, Life Sciences, or a related field (Advanced degree preferred).
- Minimum of 5 years of experience in quality assurance for active medical devices and software.
- Strong knowledge of FDA regulations (21 CFR Part 820), ISO 13485, IEC 62304 (software lifecycle), and risk management standards such as ISO 14971.
- Experience with software quality assurance, validation, and cybersecurity considerations for medical devices.
- Proven track record of working in hybrid or cross-functional environments with a focus on quality and compliance.
- Excellent problem-solving, analytical, and communication skills.
- Certifications in quality management or auditing (e.g., ASQ Certified Quality Engineer, Certified Quality Auditor) are a plus.
