Senior Quality Engineer – Medical Devices & Compliance

Hemanext, Inc.; Avon (MA); Vor Ort; USD 120.000 - 165.000; Vollzeit

Zusammenfassung

Hemanext, Inc. in Avon, MA is seeking a Sr. Quality Engineer to provide quality engineering support across operations, commercialization, and design and development of medical devices.

Strong cross-functional collaboration and project leadership are essential. Responsibilities include supplier management, NCR/CAPA handling, risk management, design control review, post-market surveillance, and ensuring compliance with ISO 13485 and 21 CFR.

Qualifikationen

• 10+ years hands-on experience with FDA QSR, ISO 13485 and MDD/MDR in a regulated medical device environment.
• Experience with design verification/validation and test methods for medical devices.
• Proficient in design controls and risk assessment techniques (FMEA, fault tree analysis, 5 Why's, Fishbone).

Aufgaben

• Support supplier management with supplier performance reviews, ASL updates, and SCARs.
• Review inspection records and process NCRs.
• Facilitate calibration of gages for calibration system.
• Manage risk management processes and post-market surveillance activities.
• Review design development and changes for justification, validation and verification updates, and risk assessments.
• Support product complaint investigations and rapid resolution of issues.
• Author CAPAs from internal or customer sources and KPI signals.
• Assist with Management Review compilations and presentations.
• Maintain compliance with ISO 13485, 21 CFR and other regulatory requirements.
• Maintain knowledge of government and industry quality assurance regulations across markets.

Kenntnisse

Communication skills

Quality systems knowledge

Project management

Documentation proficiency

Ausbildung

Bachelor's degree in science or engineering

Jobbeschreibung

Hemanext, Inc. in Avon, MA is seeking a Sr. Quality Engineer to provide quality engineering support across operations, commercialization, and design and development of medical devices.

Strong cross-functional collaboration and project leadership are essential. Responsibilities include supplier management, NCR/CAPA handling, risk management, design control review, post-market surveillance, and ensuring compliance with ISO 13485 and 21 CFR.