Lead Quality Engineer - Implantable Medical Devices

Michael Page; Danbury (CT); Vor Ort; USD 70.000 - 100.000; Vollzeit

Zusammenfassung

MPI is seeking a Quality Engineer in Danbury, CT to lead quality engineering activities for implantable medical devices, driving risk management, investigations, CAPAs, and process controls in a highly regulated environment.

You will develop validation protocols, establish QC plans and SPC methods, collaborate with customers and suppliers, and ensure ISO 13485 and FDA 21 CFR 820 compliance while supporting continuous improvement.

Qualifikationen

• Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, or related technical field.
• Experience in Quality Engineering within a medical device manufacturing environment.
• Working knowledge of ISO 13485, FDA 21 CFR 820, and regulated quality systems.
• Experience with validations, risk management, CAPA investigations, and quality documentation.
• Strong statistical analysis skills, including experience with Minitab or similar software.
• Excellent technical writing, communication, and project leadership abilities.

Aufgaben

• Lead quality engineering activities for new product introductions, process improvements, and manufacturing optimization projects.
• Drive root cause investigations, CAPAs, nonconformance resolution, and risk mitigation activities using advanced quality tools.
• Develop and execute validation protocols, test methods, equipment qualifications, and process validations.
• Establish and maintain quality control plans, SPC programs, inspection methodologies, and process monitoring systems.
• Partner with customers, suppliers, and internal stakeholders to resolve quality issues and ensure regulatory compliance.
• Support ISO 13485 and FDA-regulated operations through audits, documentation, training, and continuous improvement initiatives.

Kenntnisse

Quality Engineering

Risk management

CAPA investigations

Statistical analysis

Technical writing

Project leadership

Ausbildung

Bachelor's degree in Engineering

Tools

Minitab

Jobbeschreibung

MPI is seeking a Quality Engineer in Danbury, CT to lead quality engineering activities for implantable medical devices, driving risk management, investigations, CAPAs, and process controls in a highly regulated environment.

You will develop validation protocols, establish QC plans and SPC methods, collaborate with customers and suppliers, and ensure ISO 13485 and FDA 21 CFR 820 compliance while supporting continuous improvement.