Staff Design Quality Engineer

Stryker • Waltham, MA

1d • $93,200 - $155,400 • Hybrid

About The Position

Stryker is hiring a Staff Design Quality Engineer to support new product development and quality activities throughout the medical device product lifecycle. The role partners with Research & Development, Regulatory Affairs, Manufacturing, Supplier Quality, and Operations to support design controls, risk management, product verification and validation, design transfer, and Quality Management System compliance in a regulated medical device environment.

The position is hybrid and requires candidates to reside within commuting distance of Waltham, Massachusetts, and work onsite several days per week. The role has no travel requirement.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, Manufacturing Engineering, or a related technical discipline.
• At least 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.

Nice To Haves

• Certified Quality Engineer (CQE) certification or a comparable quality certification.
• Experience with Class II and/or Class III medical devices, including global requirements such as the European Union Medical Device Regulation and Medical Device Single Audit Program.
• Experience with statistical analysis, quality improvement methodologies, supplier quality management, auditing, software validation, or computerized system validation.

Responsibilities

• Represent Quality Engineering on cross-functional new product development teams and provide 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior