Quality Engineer | Pleasant Prairie, WI

Michael Page; Pleasant Prairie (WI); On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

3 weeks of PTO - accrues from day one

Full medical benefit plans offered on day one

Retirement plan with employer match

Ancillary benefits

Job summary

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.

Qualifications

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

Responsibilities

• 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.

Skills

ISO13485 standards knowledge

FDA standards understanding

Quality control experience

Metal fabrication experience

CNC experience

GD&T/PPAP experience

QMS software knowledge

Job description

Description

• Plan, coordinate, and execute quality control programs ensuring compliance to ISO13485 and FDA standards
• Investigate and address customer complaints - CAPA
• 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

Profile

• 5+ years of quality experience in medical device
• Understanding of ISO13485 and FDA standards
• Experience with metal fabrication required, CNC preferred
• GD&T/PPAP experience
• Knowledge of QMS software and associated document control
• Certifications a plus

Job Offer

• Salary ranging from $85,000-$100,000 depending on experience
• 3 weeks of PTO - accrues from day one
• Full medical benefit plans offered on day one
• Ancillary benefits
• Retirement plan with employer match

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.