Strong career opportunity for an experienced Quality Manager to lead and scale a Quality Engineering department in a dynamic and complex product development environment. Manage the QMS, drive regulatory compliance strategy, and supervise a team of quality professionals through the final stages of product development and into commercialization.
Responsibilities:
- Oversee and direct Quality Engineering during design phase activity including development, verification, validation, transfer, and associated design reviews for new product development and product realization.
- Manage risk management activity, ensuring proper analysis and documentation are applied throughout the product development process.
- Provide strategic quality leadership to the design engineering teams for software, data science, and hardware/systems throughout the design control process and Software Development Life Cycle (SDLC).
- Oversee sustaining engineering through operational quality activity, including material control, process development, inspection/acceptance activity, CAPA nonconforming material control, equipment qualification, supplier management, and internal audit.
- Manage personnel and resources to inspect and test materials, equipment, processes, and products to ensure quality specifications are met.
- Design, implement, and maintain quality system processes to comply with regulatory standards.
- Direct cross-functional personnel training for quality and compliance best practices and proactively mentor QA team members.
- Oversee internal audit activity, including leading the strategic preparation and organizational readiness for external ISO 13485 certification.
- Drive the expanding understanding of applicable external standards across the organization to scale compliance in preparation for product commercialization.
- Foster a culture of trust, open communication, and continuous improvement, with an unwavering focus on advancing patient outcomes.
Required Skills and Experience:
- BS or greater in mechanical or biomedical engineering or related fields.
- A minimum of 10 years of experience in quality engineering or a related role in a regulated industry, with proven experience in a leadership or managerial capacity.
- Broad experience managing quality for software, data science, hardware/systems design and productions, or with similar medical devices, while working within a QMS.
- Expert applied understanding of 21 CFR 820, ISO 13485:2016, and IEC 62304:2006.
- Demonstrated leadership experience overseeing the product development lifecycle, SDLC, design controls, and risk analysis.
- Excellent communication skills, good documentation practices (formal protocols and reports), attention to detail, and project management skills.