Quality Engineer

Company : Katalyst Healthcares & Life Sciences

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:

• Bachelor's degree in engineering required.
• Minimum 8 years of quality engineering experience in medical device manufacturing (aerospace or automotive experience also considered).
• Expertise in ISO 13485, FDA CFR820, AS9100, or IATF 16949 standards.
• Proven experience leading CAPA, Client activities, and validations in manufacturing settings.
• Experience collaborating with customers to resolve complaints and product issues.
• Advanced knowledge of metrology, GD&T, and interpreting CAD/blueprints.
• Hands-on experience with industrial machinery such as CNC, EDM, and finishing equipment preferred.
• Proficient in Minitab, Excel, and technical documentation software.
• Strong leadership, communication, and process ownership skills.

Apply Online