MGS Mfg. Group has an exciting opportunity for a Quality Engineer at our Germantown, WI molding facility. This position will interface with our customers, focus on the corrective action process and lead teams to make a difference.
A little bit about us. We are an engineering house, a toolmaker, an injection molder, a blow molder, and a custom machine builder. Through customer demand and active progression on our part, we have been expanding our services since we opened our doors in 1982. The MGS Mfg. Group adapts to the needs of our customers along with cultivating new concepts and goals within the plastic industry. Throughout our growth and constant change, we have remained a partner to our customers, suppliers, and employees by learning from them, growing with them, and most importantly, never forgetting that without them, the evolution and success of this corporation would not have been possible. To learn more visit us at www.mgstech.com.
The Quality Engineer will monitor and continuously improve upon the Quality System Elements.
Below are the essential duties and responsibilities:
- Learn and master all necessary areas of the quality system.
- Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Perform complaint, CAR and exception investigation.
- Develop rework instructions.
- Develop validation protocols, test method validation/Gage R & R and final reports. Perform data analysis. Assist in deviation investigation and resolution.
- Facilitate problem solving meeting.
- 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 inspection report.
- Provide disposition of nonconforming products.
- Initiate engineering change package.
- Support operation to resolve inspection issues to allow product movement in a timely manner.
- Continuously improve the quality system.
- 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.
- Manage new production transfer.
- Train production and QC staff.
- Any other duties as assigned.
A qualified candidate would fulfill these requirements:
- Bachelor’s degree in a science/engineering related field and 3-5 years of experience, or combination of accrued on-the-job experience and training.
- Qualification experience such as PPAP or IQ/OQ/PQ.
- Strong problem solving skills.
- Data analysis and reporting experience.
- Able to manage projects and prioritize tasks.
- Customer focused and experience working with customers.
- QS / ISO System experience.
- Understanding/working knowledge of ISO13485, ISO 16949 and FDA 21 CFR Part 820 and 11.
We offer an excellent benefits package including medical, dental, vision, 401K, disability, life, FSA, vacation, and holidays. MGS is an Equal Opportunity Employer.