Quality engineer

Quality Engineer

We are seeking a driven and detail-oriented Quality Engineer to join a dynamic team at a confidential medical device manufacturer. In this role, you will play a pivotal part in ensuring the quality, compliance, and performance of life-saving medical technologies throughout the manufacturing process and post-market lifecycle.

Key Responsibilities:

• Develop and implement robust quality plans to ensure manufacturing consistency and product conformance.
• Lead technical investigations for both manufacturing issues and customer complaints to determine root cause, implement corrective/preventive actions, and verify their effectiveness.
• Analyze product performance data using statistical tools and risk-based methodologies to identify trends, mitigate risks, and support continuous improvement efforts.
• Conduct hands-on evaluations of customer-returned devices and manufacturing nonconformities, with detailed technical documentation and reporting.
• Translate complex technical issues and solutions into clear, actionable insights for a variety of internal audiences.
• Maintain active involvement in cross-functional projects, representing the Quality function with a solutions-focused approach.
• Ensure full compliance with internal quality systems and applicable global regulatory standards, including FDA, ISO 13485, and other international medical device regulations.

Qualifications:

• Bachelor's degree in Engineering or a related technical field.
• Minimum of 2 years of quality or engineering experience in a regulated industry (medical device/FDA-regulated environment strongly preferred).
• Proven skills in project management, data analysis, root cause investigation, and risk assessment.
• Excellent communication and problem-solving skills with a hands-on, proactive mindset.