Quality Engineer II

Headquarters and the main research campus are in New York City. Since 1983, the company has built manufacturing sites in New York and abroad. We started in 1983 and have grown to about 430 people.

Overview:

We are creating this position because the workload has grown. GH Biologics is hiring a Quality Engineer II to support production and handle customer complaints at our Overland Park plant.

In this role you will:

• Review and approve PPAP submissions from suppliers
• Chair MRB meetings and disposition nonconforming material
• Analyze SPC data and process capability (Cpk) and push for process fixes
• Support customer and registrar audits
• Run MSA and gauge R&R studies
• Lead root cause analysis and corrective action using 8D and 5 Whys

You'll need:

• 3+ years of quality engineering experience in manufacturing
• Can read drawings and apply GD&T
• Hands-on with root cause tools: 8D, fishbone, 5 Whys
• Comfortable pushing back on suppliers and internal teams with data
• Able to travel up to 20% for supplier visits
• Strong technical writing for reports and procedures

Bonus points:

• FDA 21 CFR 820 experience
• CMM programming or metrology background
• ASQ CQE certification

Benefits:

Compensation: $95,000 to $127,000 a year

• Medical, dental and vision insurance
• 401(k) with 4% match
• 11 paid holidays

GH Biologics provides equal employment opportunities to all employees and applicants.

Please include a short note on why this role interests you.

Start: Immediately.

Demo job created on 11jobs for testing and demonstrations. It is not an actual opening at GH Biologics.