Quality Engineer

Responsibilities

• Know and follow all of the Company’s safety rules, such as safe work practices and standard operating procedures.
• 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 company
• 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 audits

Qualifications

• High School Diploma or equivalent is required.
• 7-10 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.