Staff Design Quality Engineer – Med Device, Hybrid

Stryker; Waltham (MA); Híbrido; USD 93.000 - 155.000; Jornada completa

Descripción de la vacante

Stryker is seeking a Staff Design Quality Engineer in Waltham, MA to support new product development and ensure quality across the medical device lifecycle. You will partner with R&D, Regulatory Affairs, Manufacturing, and suppliers to apply design controls, risk management, V&V, and ISO 13485 compliance.

This hybrid role requires a Bachelor's degree in engineering and at least four years in Quality Engineering, with knowledge of FDA 21 CFR Part 820, ISO 13485, and risk management.

Formación

• Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, Manufacturing Engineering, or a related technical discipline.
• Minimum 4 years of experience in Quality Engineering, Quality Assurance, or a related position within the medical device industry.
• Experience supporting new product development, including design control activities.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, design controls, corrective and preventive action, change management, and process validation.
• Experience using electronic Quality Management Systems.

Responsabilidades

• Represent Quality Engineering on cross-functional new product development teams, providing quality and regulatory guidance throughout the product lifecycle.
• Review and approve design control documentation, including design plans, user needs, design inputs and outputs, verification and validation protocols and reports, design reviews, and Design History File documentation.
• Apply risk management principles in accordance with ISO 14971 and participate in design reviews and product risk assessments.
• Support verification, validation, process validation, and design transfer activities to ensure established requirements and acceptance criteria are addressed.
• Evaluate product requirements, specifications, engineering changes, and manufacturing changes for quality and regulatory impact.
• Investigate product and development issues using root cause analysis and support corrective and preventive actions, nonconformances, change control, and complaint investigations.
• Maintain quality documentation and records in accordance with ISO 13485, FDA 21 CFR Part 820, and applicable global medical device requirements.
• Support internal and regulatory audits, supplier quality activities, regulatory submissions, and updates to quality procedures, work instructions, and quality system requirements.

Conocimientos

Quality engineering

Design controls

Regulatory compliance

Risk management

Root cause analysis

Educación

Bachelor's degree in Engineering or related technical discipline

Herramientas

Electronic Quality Management System

Descripción del empleo

Stryker is seeking a Staff Design Quality Engineer in Waltham, MA to support new product development and ensure quality across the medical device lifecycle. You will partner with R&D, Regulatory Affairs, Manufacturing, and suppliers to apply design controls, risk management, V&V, and ISO 13485 compliance.

This hybrid role requires a Bachelor's degree in engineering and at least four years in Quality Engineering, with knowledge of FDA 21 CFR Part 820, ISO 13485, and risk management.