Quality Assurance Engineer
2 - 5 years
Northampton, PA
Full-time
Onsite
1 month ago
About the role
The Quality Engineer plays a key role in supporting the organization’s Quality Management System. This position supports compliance with ISO 13485, FDA 21 CFR 820, and MDSAP requirements, ensuring that medical devices are developed, maintained, and improved in alignment with regulatory and patient safety expectations.
The role partners closely with Engineering to apply risk-based thinking, maintain compliant documentation, and support investigations, continuous improvement, and design-related initiatives. While design quality is the primary emphasis, this role provides broader Quality support as needed to ensure system effectiveness and compliance.
Minimum Qualifications
Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline;
Or 3+ years of experience in a regulated medical-device environment.
Working knowledge of ISO 13485, including design controls and risk management (ISO 14971).
Proficiency with quality tools such as FMEA, root cause analysis, and CAPA.
Strong communication skills and the ability to collaborate across cross-functional teams.
Preferred Qualifications
Familiarity with DHF, DMR, and technical documentation.
Experience supporting design reviews, design changes, complaints investigation, and Quality documentation.
Experience with data analysis for tracking quality system metrics.
Key Responsibilities
Participate in design reviews and provide Quality input aligned with ISO 13485 and ISO 14971.
Support risk management activities, including FMEA and risk-benefit assessments.
Support verification and validation activities through review of protocols, reports, and acceptance criteria.
Participate in investigating nonconformances, complaints, and CAPAs.
Contribute to other Quality Engineering activities as needed, including complaint investigations, post-market trending, internal audits, and management review data collection.
Maintain accurate and compliant quality records and documentation within the Quality Management System.
Support regulatory and customer audits by providing design-quality and Quality Engineering support.
The role partners closely with Engineering to apply risk-based thinking, maintain compliant documentation, and support investigations, continuous improvement, and design-related initiatives. While design quality is the primary emphasis, this role provides broader Quality support as needed to ensure system effectiveness and compliance.
Minimum Qualifications
Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline;
Or 3+ years of experience in a regulated medical-device environment.
Working knowledge of ISO 13485, including design controls and risk management (ISO 14971).
Proficiency with quality tools such as FMEA, root cause analysis, and CAPA.
Strong communication skills and the ability to collaborate across cross-functional teams.
Preferred Qualifications
Familiarity with DHF, DMR, and technical documentation.
Experience supporting design reviews, design changes, complaints investigation, and Quality documentation.
Experience with data analysis for tracking quality system metrics.
Key Responsibilities
Participate in design reviews and provide Quality input aligned with ISO 13485 and ISO 14971.
Support risk management activities, including FMEA and risk-benefit assessments.
Support verification and validation activities through review of protocols, reports, and acceptance criteria.
Participate in investigating nonconformances, complaints, and CAPAs.
Contribute to other Quality Engineering activities as needed, including complaint investigations, post-market trending, internal audits, and management review data collection.
Maintain accurate and compliant quality records and documentation within the Quality Management System.
Support regulatory and customer audits by providing design-quality and Quality Engineering support.
Skills
Medical Equipment Manufacturing