Overview
Quality Assurance Engineer Jobs in Greater Boston at One Life Science
Title: Quality Assurance Engineer
Company: One Life Science
Location: Greater Boston
Position Overview
We are currently working with a start-up that is actively seeking a highly motivated and detail-oriented Quality Engineer to join our team, focusing on the development, manufacturing, and compliance of Class II medical devices. This role is critical in ensuring the safety, efficacy, and regulatory compliance of our products throughout their lifecycle. The ideal candidate will work closely with cross-functional teams, including engineering, manufacturing, and regulatory affairs, to uphold the highest quality standards.
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Key Responsibilities
Develop, implement, and maintain quality management systems (QMS) compliant with ISO 13485:2016 and FDA Quality System Regulations (21 CFR Part 820)
Ensure proper documentation control and adherence to standard operating procedures (SOPs) for all processes
Create and maintain risk management documents, including Risk Management Plans, Risk Analyses, dFMEA, sFMEA, and pFMEA
Proactively identify and mitigate risks during product design and manufacturing phases
Collaborate with engineering teams to ensure design controls are followed during product development.
Oversee validation activities such as process validation, test method validation, and non-product software validation
Support regulatory submissions for Class II devices, including preparation for FDA 510(k) premarket notifications
Ensure compliance with special controls such as performance standards, post-market surveillance requirements, and clinical performance testing
Evaluate and qualify suppliers to ensure they meet quality standards.
Conduct supplier audits to maintain the reliability of external components or services.
Lead CAPA investigations using problem-solving tools and statistical analysis.
Implement corrective actions to address non-conformities and drive continuous improvement.
Design inspection methods and testing protocols for production equipment and final products.
Conduct statistical analysis to evaluate product precision and accuracy during production.
Monitor device performance post-market through complaint investigations and data analysis.
Use post-market surveillance data for continuous product improvement.
Qualifications
Bachelor’s degree in Engineering or a related technical field.
Minimum of 5 years of experience as a Quality Engineer in the medical device industry, preferably with Class II or III devices
Strong knowledge of FDA regulations (21 CFR Part 820), ISO 13485:2016 standards, and risk management principles
Experience with design controls, validation processes, CAPA systems, and supplier quality management
Familiarity with statistical analysis tools and problem-solving methodologies.
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This is an exciting opportunity to work on innovative Class II medical devices that make a meaningful impact on patient health. You’ll be part of a collaborative team dedicated to achieving excellence in quality engineering while navigating complex regulatory landscapes. If you are passionate about quality systems and thrive in a dynamic environment that values innovation and compliance, we encourage you to apply.
