Manufacturing Quality Engineer

About the role

The Manufacturing Quality Engineer supports the Quality Management System by working closely with design and manufacturing teams to ensure products meet design intent, performance requirements, and all applicable regulatory and internal standards. This role applies core quality engineering principles such as design control, process control, risk management, supplier quality, root cause analysis, statistical analysis, and continuous improvement.

Responsibilities

• Function as the operations quality representative during the execution of engineering projects, providing quality input and oversight throughout the project lifecycle.
• Ensure product development projects and changes to existing products comply with applicable Quality System Regulations and internal quality procedures.
• Lead and support NCMR and CAPA investigations and reports, including troubleshooting manufacturing problems and ensuring compliance with requirements.
• Collaborate with suppliers on NCMRs and supplier CAPAs to resolve quality issues and drive corrective and preventive actions.
• Participate in cross-functional teams to review and disposition nonconforming products or components.
• Participate in cross-functional teams to develop and maintain Product Risk Management Files, including Risk Management Plans, Risk Assessments, DFMEAs, PFMEAs, and Risk Management Reports.
• Prepare and review quality documentation with a high degree of accuracy, completeness, and effectiveness.
• Contribute to the development of Design Verification and Validation test plans and protocols, as well as Process Verification and Validation test plans and protocols.
• Provide guidance on product requirements compliance for verification and validation activities.
• Provide direction on sample size determination and statistical analysis for verification and validation testing.
• Participate in design reviews and FMEA reviews, ensuring that quality and risk considerations are fully addressed.
• Participate in complaint investigations and ensure that all investigations are thoroughly documented and compliant with procedures.
• Provide guidance to project teams on quality policies and procedures, including verification, validation, statistical methods, and design controls.
• Assist in training related to Special Work Orders, Receiving Inspection processes, and First Article Inspections as required.
• Engage in routine daily quality activities such as First Article Inspections (FAI), CAPA, NCMR, change order review, and team training.
• Support continuous improvement initiatives within manufacturing operations and quality processes.

Essential Skills

• 3–5 years of experience in Quality Assurance, including quality systems, standards, metrics, and tools.
• 3–5 years of experience in the medical device industry, ideally with catheter products.
• Alternatively, an associate’s degree with 10 years of experience in Quality Assurance.
• Experience working within a Quality Management System (QMS) in a manufacturing environment.
• Hands-on experience with design control and process control for medical devices.
• Practical experience in risk management, including PFMEA and other risk assessment tools.
• Experience with supplier quality activities, including collaboration on NCMRs and supplier CAPAs.
• Experience with root cause analysis and implementation of corrective and preventive actions.
• Experience with statistical analysis methods for verification and validation testing, including sample size determination.
• Knowledge of manufacturing operations and process verification and validation.
• Ability to read and interpret engineering drawings and specifications, including geometric dimensioning and tolerancing (GD&T).
• Working knowledge of medical device regulations, including FDA 21 CFR 820 and relevant ISO standards.
• Working knowledge of new product design and development processes for medical devices.
• Strong organizational skills with the ability to prioritize workflow across multiple projects and meet established timelines.
• Effective interpersonal skills for working in cross-functional teams.
• Ability to prepare and review technical and quality documentation accurately and thoroughly.

Additional Skills & Qualifications

• Bachelor of Science degree in Science, Engineering, Technology, or a related field is preferred.
• Experience in the catheter contract manufacturing or CDMO environment is highly beneficial.
• Experience with complaint investigation and documentation in a regulated environment.
• Familiarity with continuous improvement methodologies within manufacturing and quality functions.
• Experience participating in or leading design reviews and FMEA reviews.
• Knowledge of verification testing and sterilization validation is desirable.
• Comfort providing training on quality-related processes such as Special Work Orders, Receiving Inspection, and FAIs.
• Ability to work effectively in a fast-paced environment with growing project bandwidth.
• Strong communication skills to clearly convey quality requirements, findings, and recommendations to diverse stakeholders.