Senior Quality Engineer

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

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 2 nd and 3 rd party audits.
• Perform internal audit.
• Any other duties as assigned.
• Teamwork and Cooperation
• Flexibility
• Initiative
• Judgement
• Customer Focused
• Organization
• Attention to Detail
• Ability to multi-task
• Critical thinking

A qualified Senior Quality Engineer candidate would fulfill these requirements:

• 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 ISO
  13485 and FDA 21 CFR Part 820 and 11.
• Experience with ISO class 8 cleanroom.
• Experience in working with team, ability to drive change and influence cultural change.

MGS Mfg. Group is committed to providing equal employment opportunity to all applicants and employees regardless of their race, creed, color, religion, gender, age, national origin, disability, military service, protected veteran status, genetic information, sexual orientation, gender identity, transgender status, or any other characteristic protected by federal, state or local law. We are strongly committed to this policy and believe in the concept and spirit of the law.

The information you provide below is optional and your resume will be given the same consideration regardless of your answer to the following questions.

• Male
• Female
• I Decline To Answer
• Hispanic or Latino (Persons of Mexican, Puerto Rican, Cuban, South or Central America, or other Spanish culture or origin, regardless of race)
• White or Caucasian (Not Hispanic or Latino) - Persons having origins in any of the original peoples of Europe, the Middle East or North Africa.
• Black or African American (Not Hispanic or Latino) - Persons having origins in the black racial groups of Africa.
• (Not Hispanic or Latino) - Persons having origins in any of the original people of North and South America and…