Job Title: Quality Manager

Work Location: Bellingham, MA and Providence, RI (split between both locations)

Summary:

The Quality Manager is responsible for ensuring compliance with ISO 13485 and other regulatory standards, maintaining and improving quality systems, and supporting teams to deliver products that meet both customer and regulatory expectations. This role oversees quality processes, leads audits, and drives continuous improvement initiatives within the organization.

Responsibilities:

• Oversee the development, implementation, and maintenance of the Quality Management System (QMS) to ensure compliance with ISO 13485 and relevant regulations.
• Lead internal and external audits, including those conducted by customers and third-party certifiers, ensuring audit readiness and follow-up on findings.
• Supervise inspection, testing, and product release processes to guarantee adherence to quality specifications and standards.
• Mentor and manage the quality assurance team, providing training and fostering professional development.
• Investigate non-conformances and customer complaints, conducting root cause analysis and implementing corrective and preventive actions (CAPAs).
• Monitor and report on key quality performance indicators (KPIs) to senior management, identifying trends and areas for improvement.
• Collaborate with production, engineering, and supply chain teams to uphold quality standards throughout manufacturing operations.
• Drive continuous improvement projects, focusing on process optimization, risk management, and validation of design and manufacturing processes.

Qualifications:

• Bachelor’s degree in Engineering, Quality Management, or a related field.
• Minimum 5 years of experience in Quality Assurance or a similar role, preferably in the medical device manufacturing sector.
• Strong knowledge of ISO 13485, FDA regulations, and other medical device standards.
• Demonstrated experience leading audits and managing quality systems.
• Excellent analytical and problem-solving skills.
• Outstanding communication and leadership abilities.
• Proficiency with quality management tools and software, such as QMS platforms and CAPA systems.
• Detail-oriented with a strong focus on compliance and regulatory requirements.
• Strong organizational and project management skills.
• Ability to work collaboratively with cross-functional teams and drive continuous improvement initiatives.
• Experience managing supplier quality processes, including qualification, audits, and performance monitoring.
• Willingness to travel occasionally for supplier audits or customer visits.

Published Category: Quality & Validation