Job DescriptionMGS Mfg. Group has an exciting opportunity for a
Sr. Quality Engineer at our Richfield, WI molding facility. The
Sr. Quality Engineer will be responsible for new product introduction, maintaining and ensuring adherence to customer specifications, supporting production, leading customer complaints, recommending updates to the quality management system and aiding with NCMR/MRB activities. This position will have direct interaction with customers and provide expertise in medical manufacturing.
Below are additional duties and responsibilities:
- Perform batch record review to release products.
- Develop, review and approve validation protocols and final reports. Analyze the validation data. Assist in deviation resolution and corrective actions.
- Facilitate audit finding and complaint investigation meeting.
- Review and approve complaint, CAR and exception report.
- Act as a liaison between customer and MGS.
- Act as subject matter experts on quality system processes.
- Assist in development of control plan, PFMEA, visual criteria, manufacturing work instruction, incoming inspection plan and in process inspection report for new products.
- Provide disposition of nonconforming products.
- Review and approve engineering change package.
- Update manufacturing related procedures and quality system procedures to address gaps.
- Mentor QEs in their daily tasks.
- Continuously improve the quality system.
- Acts as backup for the quality manager during 2nd and 3rd party audits.
- Perform internal audit.
- Any other duties as assigned.
Experience and SkillsA qualified candidate would fulfill these requirements:
- Seven to ten years of experience and/or training, or equivalent combination of education and experience.
- Medical manufacturing experience, including FDA, ISO 13485, and cleanroom manufacturing.
- Internal auditing and MedAccred is a plus.
- QS / ISO System experience.
- Previous auditing experience.
- Experience with ISO class 8 cleanroom.
- Experience in working with a team, ability to drive change and influence cultural change.
To apply and learn more about MGS Mfg. Group, go to www.mgscareers.com.
Succeed with MGS!
