Sr. Quality Engineer

MGS Mfg. Group has an exciting opportunity for a Sr. Quality Engineer at our Richfield, WI molding facility. We are a best-in-class custom manufacturer delivering plastics solutions in tooling, molding, and equipment technologies to help customers bring innovative products to market, with a focus on medical manufacturing.

About the role

The Sr. Quality Engineer will lead new product introduction, ensure adherence to customer specifications, support production, manage customer complaints, recommend updates to the quality management system, and assist with NCMR/MRB activities. This position involves direct customer interaction and expertise in medical manufacturing.

Responsibilities

• Perform batch record review to release products.
• Develop, review, and approve validation protocols and final reports.
• Analyze validation data.
• Assist in deviation resolution and corrective actions.
• Facilitate audit findings and complaint investigation meetings.
• Review and approve complaints, CARs, and exception reports.
• Act as a liaison between customers and MGS.
• Serve as a subject matter expert on quality system processes.
• Assist in developing control plans, PFMEAs, visual criteria, manufacturing work instructions, incoming inspection plans, and in-process inspection reports for new products.
• Provide disposition of nonconforming products.
• Review and approve engineering change packages.
• Update manufacturing and quality system procedures to address gaps.
• Mentor Quality Engineers in their daily tasks.
• Continuously improve the quality system.
• Act as backup for the Quality Manager during 2nd and 3rd party audits.
• Perform internal audits.
• Perform any other duties as assigned.

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 experience is a plus.
• QS/ISO system experience.
• Previous auditing experience.
• Experience with ISO Class 8 cleanroom.
• Ability to work within a team, drive change, and influence cultural change.