Quality Engineer

Responsibilities

• Provide comprehensive quality support for operations and NPI activities, ensuring compliance with ISO 13485 (or AS9100 / IATF 16949) and FDA CFR820 standards.
• Lead and document root cause analyses, CAPA, and nonconformance investigations for customer complaints, supplier issues, and nonconforming materials.
• Support and document validation efforts (IQ / OQ / PQ) for processes, equipment, and products; maintain validation documentation.
• Perform capability studies (Cpk), FMEA, and advanced metrology practices (GD&T); analyse and organize data using Minitab, Excel, and related tools.
• Resolve customer complaints and product issues, maintaining professional communication and data-driven solutions.
• Collaborate with inspectors and technicians on product inspection and testing using vision systems, CMMs, calliper's, micrometres, and more.
• Interface with suppliers and internal teams to drive process improvements, maintain documentation control, and foster a continuous improvement culture.
• Ensure all quality activities align with regulatory, customer, and internal requirements; participate in internal and external audits.

Requirements

Katalyst HealthCares & Life Sciences

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