Job Description

Sr. Quality Assurance Engineer – Medical Devices- Full Time Permanent - 5 Days Onsite

We are seeking a Sr. Quality Assurance Engineer to support product development and ensure design quality within a fast-paced, Class III medical device environment. This individual will play a critical role in risk management activities and design validation processes to support innovative cardiovascular technologies.

Key Responsibilities:

• Lead and review risk management activities, including DFMEA.
• Evaluate and approve design documentation throughout the development lifecycle.
• Support design verification and validation, including test method validation.
• Collaborate cross-functionally with engineering and manufacturing to ensure quality integration into design and production processes.
• Investigate non-conformances and drive corrective/preventive actions.
• Participate in internal audits and ensure compliance with quality system regulations.

Qualifications:

• Bachelor’s degree in engineering, life sciences, or related field.
• Minimum 5 years of experience in an FDA-regulated medical device environment.
• Solid knowledge of design control, risk management, and validation (IQ/OQ/PQ).
• Strong organizational and communication skills.

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