Senior Engineer, Quality Systems

Job Duties

• Aid in routine and periodic internal and external audits to ensure QMSR / ISO compliance.
• Review internal audit responses to ensure consistency with policy. Support all departments in executing the internal audit schedule and policy. Provide quality system support during audits, external audits, and inspections.
• Support Document and Change Control processes and systems, including maintaining and improving database reports and ancillary systems.
• Support CAPA and Audit processes and systems, including ongoing maintenance and improvement of database reports and ancillary systems.
• Serve as the CAPA Coordinator, backup CAPA Lead, and CAPA mentor for CAPA Owners.
• Define implementation approach, deliverables, governance, risks, success criteria, and escalation pathways for cross-functional projects.
• Provide review of QMS changes, procedures, training plans, records, dashboards, and implementation evidence. Support and review of Quality Management Reviews (QMRs).
• Support and lead cross-functional meetings, align stakeholders, remove barriers, and drive action closure.
• Drive process standardization, compliance technology adoption, digital workflow improvements, and continuous improvement (or 6-sigma kaizen projects). Maintain and improve QMS processes, procedures, and systems to ensure continued compliance with documented requirements and standards.
• Support continuous improvement projects related to quality management systems. Support quality system data collection and provide regular reports to management on quality system topics such as Audit status, CAPAs, Deviations, Nonconformances, Validations, and Change Controls.
• Develop curriculum to provide training and support for established quality systems.
• Perform other duties as required.

Job Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Compliance, or related discipline.
• Training in medical device QMS requirements, validations (hardware and software), quality planning, audit support, risk management, project leadership, remediation management, and Good Documentation Practices.
• Minimum of 5 years of experience in Quality Systems, Quality Engineering, Compliance, Regulatory, Engineering, Operations, or a related field.
• Experience leading quality plans, QMS remediation, policy implementation, regulatory inspection readiness, process standardization, compliance technology implementation (validations).
• Experience mentoring cross-functional team members on quality concepts and preparing compliance updates to management.
• Strong technical writing, risk-based thinking, stakeholder management, executive communication, and project leadership skills.
• Ability to coach and influence cross-functional teams without direct authority.
• Ability to translate regulatory and procedural requirements into practical implementation plans.
• In office work environment.
• Frequent cross-functional engagement across sites and process ownership teams.
• Work may include time-sensitive deliverables, audit readiness support, inspection response, remediation tracking, and leadership reporting.
• Requires the ability to manage multiple priorities and support business needs across time zones.