Staff Design Quality Engineer

Stryker; Waltham (MA); Híbrido; USD 93 000 - 155 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Conhecimentos

Quality engineering

Design controls

Regulatory compliance

Risk management

Root cause analysis

Formação académica

Bachelor's degree in Engineering or related technical discipline

Ferramentas

Electronic Quality Management System

Descrição da oferta de emprego

Staff Design Quality Engineer

Waltham – MA

Join Stryker as a Staff Design Quality Engineersupporting new product development and quality activities throughout the medical device product lifecycle. In this role, you will partner 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.

Work Flexibility

Hybrid: candidates must reside within commuting distance of Waltham – MA and be able to work onsite several days per week.

What you will do

• 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.

What you will need

Required

• 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.

Preferred

• 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.

US20: $93,200 - $155,400 USD Annual