Staff Design Quality Engineer - Medical Devices (Hybrid)

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

Job summary

Stryker is seeking a Staff Design Quality Engineer to support new product development and quality activities across the medical device lifecycle, partnering with R&D, Regulatory Affairs, and Manufacturing to ensure design controls, risk management, and product validation.

Hybrid: reside near Waltham, MA and work onsite several days per week. The role focuses on ISO 13485, FDA 21 CFR Part 820, ISO 14971, design transfer, CAPA, and continuous improvement through cross-functional collaboration.

Qualifications

• 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, CAPA, change management, and process validation.
• Experience using electronic Quality Management Systems.

Responsibilities

• 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.

Skills

Quality engineering

Regulatory knowledge

Analytical problem-solving

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Tools

Electronic QMS software

Job description

Stryker is seeking a Staff Design Quality Engineer to support new product development and quality activities across the medical device lifecycle, partnering with R&D, Regulatory Affairs, and Manufacturing to ensure design controls, risk management, and product validation.

Hybrid: reside near Waltham, MA and work onsite several days per week. The role focuses on ISO 13485, FDA 21 CFR Part 820, ISO 14971, design transfer, CAPA, and continuous improvement through cross-functional collaboration.