Staff Design Quality Engineer

• ◆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

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.

• ✓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.

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

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