Quality Engineer Job in Gurgaon at Ahead

Ahead is hiring for the role of Quality Engineer!

Responsibilities of the Candidate:

• Collaborate with cross-functional teams to meet customer expectations for new and existing products.
• Contribute to product design, development, and implementation, providing feedback on corrective and preventive actions.
• Review and approve Engineering Change Orders (ECO) and support material review board (MRB) processes.
• Conduct risk management activities, including Failure Mode & Effects Analysis (FMEA) for new products.
• Analyze quality data, identify problem areas, and recommend improvements.
• Investigate and review customer complaints, ensuring thorough root cause analysis and robust corrective actions.
• Conduct internal and vendor quality audits per regulatory, customer, and QMS requirements.
• Facilitate cross-functional Kaizen events to identify risks and drive continuous improvement.

Requirements:

• Working knowledge of ISO 9001:2015, 13485:2016, and 14971:2019 regulatory certifications.
• Familiarity with 21 CFR 820 Quality System Regulations for Medical Devices.
• Experience with medical device certification is a plus.
• Ability to interact effectively with vendors, customers, and management.
• Strong organizational skills to manage and prioritize multiple projects.
• Background in Manufacturing or Mechanical Engineering, with familiarity in quality tools like APQP, PFMEA, SPC, MSA, PPAP, SRR, and DOE.