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Re:Build Manufacturing · 3 days ago

Quality Systems Engineer

Wilmington, MA

Full-time

Onsite

Senior Level

$110K/yr - $140K/yr

5+ years exp

Re:Build Manufacturing is a growing product design and engineering consulting firm located in Wilmington, MA. They are seeking a highly motivated and detail-oriented Quality Systems Engineer to oversee the development and maintenance of the quality management system in accordance with ISO 13485 and ensure compliance with regulatory requirements.

IndustrialIndustrial AutomationIndustrial ManufacturingMachinery ManufacturingManufacturing

Responsibilities

Lead the quality management system (QMS): Oversee the development, implementation, and maintenance of the QMS in accordance with ISO 13485

Manage compliance: Ensure that all processes are compliant with regulatory and statutory requirements through regular audits and inspections

Drive continuous improvement: Identify opportunities for quality process enhancements and lead initiatives to improve efficiency and compliance

Support design transitions to manufacturing: Work with the product development consulting team to help transition prototype designs into controlled manufacturing processes

Collaborate with internal teams: Work with cross-functional teams, including product development, manufacturing, and regulatory affairs, to ensure product quality and adherence to QMS procedures

Oversee audits and inspections: Manage internal and external audits, prepare for regulatory inspections, and address any non-conformances or corrective actions

Train and mentor staff: Provide training and guidance on quality system procedures, best practices, and regulatory requirements

Monitor performance metrics: Track quality metrics, such as non-conformances and corrective actions, and report on QMS performance to senior leadership

Qualification

ISO 13485Quality Management SystemsRegulatory AuditsCAPA ProcessesRisk ManagementQuality ControlAnalytical MindsetLeadership SkillsAttention to DetailTeam PlayerCommunication Skills

Required

At least 5+ years of experience in quality management within a regulated industry, ideally in medical devices or a related field

Deep understanding of ISO 13485 and other applicable regulatory standards

Bachelor's degree in Engineering, Life Sciences, or a related technical field

Strong leadership skills with the ability to influence and work cross-functionally

Excellent written and verbal communication skills to convey complex quality concepts clearly and effectively

Thorough understanding of quality management systems, regulatory audits, CAPA processes, risk management, and quality control

Meticulous attention to detail, ensuring all processes, documentation, and audits meet regulatory requirements and industry best practices

A collaborative approach with a passion for mentoring and training others in quality best practices

A results-driven attitude with a genuine commitment to upholding the highest quality standards and ensuring company success through rigorous adherence to quality and regulatory requirements

Preferred

An advanced degree or certifications (e.g., CQE, CQA) in quality management

Experience with document control systems and quality software tools

Benefits

Every employee of Re:Build will share ownership in the company and share in the financial rewards of the success we achieve together, at all company levels!

Company

Re:Build Manufacturing

Re:Build Manufacturing is a family of industrial businesses combining cutting-edge enabling technologies, operational superiority and strategic M&A to build America’s next generation industrial company.

Founded in 2020

Framingham, Massachusetts, USA

1001-5000 employees