Senior Quality Systems Engineer

Quality Systems Engineer

The Quality Systems Engineer is responsible for ensuring an efficient and compliant Quality Management System (QMS), including analysis, development, and revision of QMS processes, performance monitoring, and continuous improvement to ensure accuracy and compliance with relevant standards.

• Takes ownership of quality processes including audits, document control, training, CAPA, etc. ensuring that QMS is efficient and meets regulatory requirements.
• Analyzes QMS metrics and performance indicators, prepares detailed reports that highlight trends, deviations, and areas for improvement, and presents findings to senior management.
• Contributes to the development, implementation, and revision of QMS processes, including SOPs, work instructions, and quality manuals, ensuring their accuracy, clarity, and compliance with relevant standards.
• Conducts risk assessment activities, identifying potential risks to regulatory compliance, quality, and QMS integrity, and develops robust mitigation strategies to minimize impact.
• Participates in continuous improvement initiatives within QMS, proposes and implements 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.
• Participates 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 such as 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 provides responses to audit findings in collaboration with stakeholders.

• Minimum 5+ years’ experience in FDA‑regulated (ISO 13485) medical device quality operations/manufacturing environments, focusing on QMS compliance, documentation, gap assessments, audits, document control, training, CAPA, etc.
• Experience managing/maintaining training metrics or matrix.
• Proven experience leading cross‑functional teams and ability to mentor less experienced engineers.
• Detailed experience in CAPA processes, including problem identification, root cause analysis/tools, implementation of solutions to prevent recurrence, and drive continuous improvement.
• Experience in data analysis, understanding QMS metrics/KPI, preparing detailed reports that highlight trends, deviations, and areas for improvement, and presenting findings to senior management.
• Ability to build and cultivate relationships with supervisors, functional peer groups, internal/external stakeholders, and suppliers.
• Minimum bachelor’s degree (required) in Quality, Engineering, or a similar discipline. ASQ‑CQE or ISO Lead Auditor certifications are desirable.
• Can perform the minimum physical, cognitive, and environmental job requirements with or without accommodation for this position.

Work in‑person at our office at least 3 days per week. On‑site roles require full‑time (5 days per week) presence in company facilities. Field roles are performed at customer or supplier sites, generally outside the main facilities. This is an on‑site role.

The pay range for this position in Bedford, MA is $102,480 to $163,968. The actual base pay offered may vary within the posted ranges depending on job‑related knowledge, skills, experience, business needs, geographic location, and internal equity. Other compensation, such as an annual incentive bonus, sales commission, or long‑term incentives, may be offered.

Employees are eligible to participate in our comprehensive Total Rewards benefits…