Supplier Quality Engineer (Medical Device)

Quality, regulatory and pharmacovigilance groups work across every site. Granitekeep Therapeutics is a global biopharmaceutical company with medicines approved in more than 60 countries.

Position summary

Granitekeep Therapeutics is hiring a Supplier Quality Engineer (Medical Device) to support production and handle customer complaints at our New York City plant. This is an in-person role at our New York City location.

Day to day

• Analyze SPC data and process capability (Cpk) and push for process fixes
• Review and approve PPAP submissions from suppliers
• Develop control plans, inspection plans and PFMEAs with manufacturing
• Lead root cause analysis and corrective action using 8D and 5 Whys
• Validate processes through IQ, OQ and PQ
• Chair MRB meetings and disposition nonconforming material

Qualifications

• 3-5 years of quality engineering experience in manufacturing
• Able to travel up to 20% for supplier visits
• Proficient in Minitab or similar statistical software
• Hands-on with root cause tools: 8D, fishbone, 5 Whys
• Can read drawings and apply GD&T
• Bachelor's degree in engineering or a related technical field

Nice to have

• APQP and PPAP for automotive
• CMM programming or metrology background

Schedule: Monday to Friday, 7:30 AM to 4:30 PM

Compensation: $114,000 - $142,000 a year DOE.

Perks and benefits

• Health savings account (HSA) with employer contribution
• 401(k) with 4% match
• Three weeks of PTO to start
• Referral program
• Relocation assistance
• Medical, dental and vision insurance
• Health insurance

Granitekeep Therapeutics is an Equal Opportunity Employer, including disability and protected veteran status.

Start: Immediately.

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