Our client located in Germantown, WI is a market leader in their industry and work with a diverse customer base. To support their growth, they are seeking a Quality Engineer, with previous experience working in a manufacturing environment preferably within the Automotive or Medical industries.
What you will be doing?
- Perform complaint, CAR and exception investigation.
- Develop validation protocols, test method validation/Gage R & R and final reports. Perform data analysis. Assist in deviation investigation and resolution.
- Interface with customer to resolve complaint, corrective actions, preventive actions, engineering changes and validation / PPAP activities.
- Update production documents including control plan, PFMEA, visual inspection criteria, incoming inspection plan and in process inspectionreport.
- Provide disposition of nonconforming products.
- Initiate engineering change packages
- Assist in 2nd,3rd party, and internal audits.
- Assist in formulating responses to audit findings.
- Perform batch record review and generate the Certificate of Analysis..
What you will need?
- Bachelor?s degree in a science/engineering related field and 3-5years of experience, or combination of accrued on-the-job experience and training.
- Strong problem solving and corrective action skills
- Data analysis and reporting experience.
- Experience with PPAP or IQ/OQ/PQ preferable.
- Customer focused and experienceworking with customers.
- Experienceworking withISOaudits and coordinating customer audits.
- Understanding/working knowledge of ISO13485, ISO16949 and FDA 21 CFR Part 820 and 11.
So if you are looking to join a fast paced, dynamic work environment with ample professional growth potential, then apply today!