Senior Quality Engineer

MGS Mfg. Group; Town of Richfield (WI); On-site; USD 85,000 - 125,000; Full time

Job summary

MGS Mfg. Group is seeking a Senior Quality Engineer to monitor and continually improve the Quality System elements at our facility in Wisconsin. You will lead compliance with GMP/GDP, review batch records, validate protocols, and drive corrective actions.

The role requires hands-on auditing experience, ISO13485 knowledge, and the ability to mentor QA staff while supporting customer needs. Strong collaboration with cross-functional teams and a commitment to continuous quality improvement are

Qualifications

• High School Diploma or equivalent required.
• Seven to ten years of experience and/or training, or equivalent combination of education and experience.
• QS / ISO System experience.
• Understanding/working knowledge of ISO13485 and FDA 21 CFR Part 820 and 11.
• Previous auditing experience.
• Experience with ISO class 8 cleanroom.
• Experience in working with team, ability to drive change and influence cultural change.

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.
• Mentor QEs in their daily tasks.
• Act as a liaison between customer and MGS.
• Act as subject matter experts on quality system processes.
• Review and approve engineering change package.
• Continuously improve the quality system.
• Acts as backup for the quality manager during 2nd and 3rd party audits.

Education

High School Diploma or equivalent

Job description

Summary

Job Description:

The Senior Quality Engineer is responsible to monitor and continuously improve upon the Quality System Elements.

Essential Functions

Qualification for this position is predicated not only on satisfactory performance of essential duties as outlined below, but also on compliance with general company policies and procedures and any other duties as assigned. Strict compliance with Company's Attendance Policy is considered an essential duty and responsibility. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Know and follow all of the Company's safety rules, such as safe work practices and standard operating procedures.
• Serve as a good role model to employees for safe work practices and behavior by conducting yourself professionally, keeping in mind your own safety and the safety of others.
• Learn and master all necessary areas of the quality system.
• Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• 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.

Competencies

• Positive Attitude
• Teamwork and Cooperation
• Flexibility
• Initiative
• Judgement
• Customer Focused
• Organization
• Attention to Detail
• Ability to multi-task
• Critical thinking
• Communication skills

Required Experience

• High School Diploma or equivalent is required.
• Seven to ten years of experience and/or training, or equivalent combination of education and experience.
• QS / ISO System experience.
• Understanding/working knowledge of ISO13485 and FDA 21 CFR Part 820 and 11.
• Previous auditing experience.
• Experience with ISO class 8 cleanroom.
• Experience in working with team, ability to drive change and influence cultural change.

MGS is an Equal Opportunity Employer.

Benefits

To learn more about MGS Mfg. Group, go to www.mgsmfg.com. We offer a competitive benefits package including medical, dental and vision insurance, company paid life and disability insurance, paid time off, and a generous 401(k) match.

Keyword: Process Engineer