Are you passionate about ensuring high-quality, reliable products? Join our client as a Quality Engineer!

About the Role

As a Quality Engineer, you’ll ensure their medical devices, materials, components, and manufacturing processes produce top-tier products. You’ll develop and implement methods to inspect, test, and evaluate product reliability.

Key Responsibilities

• Quality Assurance: Ensure materials and processes produce high-quality products.
• Inspection & Testing: Develop inspection criteria and verify conformance with specifications.
• Method Development: Create sampling, inspection, and testing methods using statistical tools.
• Collaboration: Integrate quality considerations into manufacturing procedures and training.
• Equipment Management: Maintain and coordinate equipment calibrations.
• Customer Interaction: Participate in customer specifications and risk assessments.
• Team Leadership: Lead teams in investigating quality issues and managing the CAPA program.
• Training: Provide training to quality assurance team members.
• Communication: Interact with customers to support quality objectives.

What We're Looking For

• Education: Bachelor’s degree in a scientific or engineering field.
• Experience: 3+ years in a quality engineering role in the medical device industry or similar.
• Regulatory Knowledge: Experience with Quality Management Systems (ISO 9001, ISO 13485, FDA QSR, cGMP 21 CFR Part 820, ISO 14971).
• Technical Skills: Proficiency in Microsoft Office and database management; SolidWorks or 3D CAD skills are a plus.
• Communication: Excellent written and verbal skills in English.
• Analytical Skills: Strong problem-solving and decision-making abilities.
• Certifications: Six Sigma, CQE, or CQA preferred.

Why Join Us?

Our client offers a collaborative, innovative environment where your contributions are valued. Lead significant quality initiatives and work with a dedicated team committed to excellence.