Hologic is looking for a Manager, Quality Engineering for Quality Technical Investigations (QTI) to manage a multidisciplinary team responsible for technical complaint investigations, root cause analysis, and continuous improvement for their electromechanical in vitro diagnostics medical devices (IVDs). The goal is to ensure the successful development and launch of safe, durable, and serviceable products.
Requirements
- Deep understanding of Quality Management Systems (QMS), including ISO 13485 and FDA QMSR regulations.
- Expertise in root cause analysis, CAPA, complaint investigations, and systemic issue resolution.
- Knowledge of 5S principles for lab organization and safety.
- Familiarity with new product development processes and lifecycle management for medical devices.
- Advanced knowledge of electromechanical and IVD medical device standards and best practices.
- 7+ years of quality engineering experience in the medical device industry, with a focus on electromechanical and IVD devices.
- Proven track record in complaint investigations, CAPA processes, and regulatory compliance.
Responsibilities
- Manage a multidisciplinary team responsible for technical complaint investigations, root cause analysis, and continuous improvement for our electromechanical in vitro diagnostics medical devices (IVDs).
- Play a pivotal role in ensuring the successful development and launch of safe, durable, and serviceable products.
- Systematic approach to identifying root causes, implementing corrective actions, and driving continuous improvement.
- Developing and improving processes to maintain compliance, audit readiness, and efficiency.
- Supporting new product development and launches.
- Supporting regulatory audits and maintaining audit-ready processes.
- Managing laboratory or technical workspaces, including implementing 5S principles.
Other
- Proven ability to lead, mentor, and develop multidisciplinary teams of engineers and technicians.
- Strong ability to foster cross-functional partnerships with design, manufacturing, and service teams.
- Excellent written, verbal, and interpersonal communication skills to foster a solutions-oriented team culture.
- Strong organizational and documentation skills with an emphasis on data-driven decision-making.
- Experience in a leadership or management role, with direct responsibility for engineering or technical staff.
