Quality Engineer

AHEAD is seeking a Quality Engineer to join their team. This role focuses on collaborating with cross-functional teams to ensure customer satisfaction for both new and existing products. Key responsibilities include contributing to product design and development, reviewing Engineering Change Orders (ECO), managing risk through Failure Mode & Effects Analysis (FMEA), and analyzing quality data to recommend improvements. The role also involves investigating customer complaints, conducting quality audits, and facilitating continuous improvement through Kaizen events.

Key Responsibilities:

• Collaborate with cross-functional teams to meet customer expectations
• Contribute to design, development, and implementation of new products
• Review and approve Engineering Change Orders (ECO)
• Conduct risk management activities, including FMEA for new products
• Analyze quality data and recommend improvements
• Investigate customer complaints and ensure thorough root cause analysis
• Conduct internal and vendor quality audits
• Facilitate Kaizen events for continuous improvement

Required Skills:

• Knowledge of ISO certifications 9001:2015, 13485:2016, and 14971:2019
• Familiarity with 21 CFR 820 Quality System Regulations for Medical Devices
• Strong organizational and multi-tasking skills
• Ability to interact effectively with vendors, customers, and management
• Background in Manufacturing or Mechanical Engineering is a plus
• Experience with quality tools like APQP, PFMEA, SPC, MSA, PPAP, SRR, and DOE

AHEAD values diversity and provides opportunities for growth through cross-department training, certifications, and access to top-notch technologies. They offer competitive benefits including medical, dental, and vision insurance, 401(k), paid time off, and parental leave.