Staff Design Quality Engineer, Medical Devices (Hybrid—Waltham)

Stryker; Waltham (MA); Hybrid; USD 93,000 - 155,000; Full time

Job summary

Stryker in Waltham, MA is seeking a Staff Design Quality Engineer to support new product development and quality activities across the medical device lifecycle.

You will partner with R&D, Regulatory, Manufacturing, and Supplier Quality to ensure design controls, risk management, verification/validation, design transfer, and QMS compliance in a regulated environment. Hybrid onsite several days a week.

Qualifications

• Bachelor’s degree in Engineering or a related technical discipline.
• 4+ years in Quality Engineering or Quality Assurance in the medical device industry.
• Experience supporting new product development, including design controls.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, design controls, CAPA, change control, and process validation.
• Experience with electronic Quality Management Systems.

Responsibilities

• Represent Quality Engineering on cross-functional NPD teams, providing quality and regulatory guidance.
• Review and approve design control documentation, including design plans, user needs, design inputs/outputs, verification/validation protocols and reports, design reviews, and DHF documentation.
• Apply risk management principles per ISO 14971 and participate in design reviews and risk assessments.
• Support verification, validation, process validation, and design transfer activities.
• Investigate issues using root cause analysis and support CAPA, nonconformances, change control, and complaint investigations.
• Maintain quality documentation in line with ISO 13485, FDA 21 CFR Part 820, and global medical device requirements.
• Support audits, regulatory submissions, and updates to quality procedures and work instructions.

Skills

Quality engineering

Design controls

Risk management

Regulatory knowledge

Education

Bachelor’s degree in Engineering or related technical discipline

Tools

Electronic Quality Management System

Job description

Stryker in Waltham, MA is seeking a Staff Design Quality Engineer to support new product development and quality activities across the medical device lifecycle.

You will partner with R&D, Regulatory, Manufacturing, and Supplier Quality to ensure design controls, risk management, verification/validation, design transfer, and QMS compliance in a regulated environment. Hybrid onsite several days a week.