Senior Quality Systems Engineer

Your role

• Takes ownership of Quality processes including-Audits, Document Control, Training, CAPA etc. ensuring that QMS is efficient and meets the regulatory requirements.
• Analyzes QMS metrics and performance indicators, preparing detailed reports that highlight trends, deviations, and areas for improvement, and presenting findings to senior management.
• Contributes to the development, implementation, and revision of QMS processes, including standard operating procedures (SOPs), work instructions, and quality manuals, ensuring their accuracy, clarity, and compliance with relevant standards.
• Conducts risk assessments activities, identifying potential risks to regulatory compliance, quality and QMS integrity, and developing robust mitigation strategies to minimize their impact.
• Participates in continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to drive overall quality performance and operational excellence.
• Applies specialized knowledge in breadth and/or depth to a variety of issues and projects within the team, ensuring effective solutions and innovative approaches to complex challenges.
• Participate in training sessions to stay updated on quality standards and QMS procedures, actively engaging in learning opportunities to enhance understanding of industry regulations and best practices.
• Cultivates effective relationships with internal and external partners, providing influence over projects and peer groups by demonstrating a comprehensive understanding of the area of specialization.
• Leads cross-functional problem-solving sessions to address significant QMS issues, utilizing structured methodologies like root cause analysis and driving the implementation of solutions.
• Prepares for and participates in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provide responses to audit findings in collaboration with stakeholders.

You're the right fit if

• You have a minimum of 5+ years' experience in FDA/ISO 13485 medical device quality operations/manufacturing environments, with a focus on QMS compliance, documenting QMS changes, gap assessments, Audits, Document Control, Training, CAPA's, etc.
• You have experience managing/maintaining training metrics/matrix.
• You have proven experience leading cross-functional teams and the ability to mentor less experienced engineers.
• You have detailed experience/knowledge in CAPA processes, including problem identification, root cause analysis/tools, implementation of solutions to prevent recurrence and drive continuous improvement.
• You're experienced in Data analysis, understanding QMS metrics/key performance indicators (KPI), preparing detailed reports that highlight trends, deviations, areas for improvement, and presenting findings to senior management.
• You're able to build/cultivate relationships with supervisors, functional peer groups, internal/external stakeholders, suppliers etc.
• You have a minimum of a Bachelor's Degree (Required), in Quality, Engineering or similar disciplines. ASQ-CQE, ISO Lead Auditor certifications-desired.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.