Quality Engineer, Medical Devices — ISO13485 / FDA QMS Lead

Michael Page; Pleasant Prairie (WI); Vor Ort; USD 85.000 - 100.000; Vollzeit

Benefits dieser Stelle

3 weeks of PTO - accrues from day one

Full medical benefit plans offered on day one

Retirement plan with employer match

Ancillary benefits

Zusammenfassung

A recruitment firm is looking for a Quality Control Specialist in Pleasant Prairie, Wisconsin. The ideal candidate will have over 5 years of quality experience in the medical device industry, with a strong understanding of ISO13485 and FDA standards. Responsibilities include executing quality control programs, handling audits, addressing customer complaints, and maintaining process documentation. Salary ranges from $85,000 to $100,000 depending on experience, alongside benefits including PTO and medical plans.

Qualifikationen

• 5+ years of quality experience in medical device.
• Understanding of ISO13485 and FDA standards.
• Experience with metal fabrication required, CNC preferred.
• Certifications a plus.

Aufgaben

• Plan, coordinate, and execute quality control programs ensuring compliance to ISO13485 and FDA standards.
• Investigate and address customer complaints.
• Assist with preparing and executing internal and external audits.
• Handle document and process controls.
• Update documentation and data within the QMS.
• Create and direct validations (IQ/OQ/PQ).
• Create PPAP documentation.

Kenntnisse

ISO13485 standards knowledge

FDA standards understanding

Quality control experience

Metal fabrication experience

CNC experience

GD&T/PPAP experience

QMS software knowledge

Jobbeschreibung

A recruitment firm is looking for a Quality Control Specialist in Pleasant Prairie, Wisconsin. The ideal candidate will have over 5 years of quality experience in the medical device industry, with a strong understanding of ISO13485 and FDA standards. Responsibilities include executing quality control programs, handling audits, addressing customer complaints, and maintaining process documentation. Salary ranges from $85,000 to $100,000 depending on experience, alongside benefits including PTO and medical plans.