Quality Engineer III

Quality Engineer III | Direct Hire | Maple Grove, MN | Medical Device Industry

Responsibilities

• Support manufacturing lines by investigating CAPAs, nonconformities, and complaints.
• Mentor manufacturing and engineering staff on root cause techniques and problem solving.
• Evaluate change requests from manufacturing to ensure adequate justification and verification.
• Mentor manufacturing and engineering on the formulation of impact assessments and justifications.
• Provide input and expertise to manufacturing on sample sizes and statistical methods.
• Develop and maintain the pFMEA process for manufacturing.
• Develop and execute to Validation Master Plans, Equipment Qualifications, Process Validations, and test method validations for successful transfer from development to manufacturing working in a cross-functional group.
• Support/participate in regulatory agency and customer quality audits.
• Participate in design control activities to ensure that product meet specifications, reliability, and manufacturability.
• Identify and process CAPAs and Nonconformity Reports to drive to root cause analysis and practical corrective and preventive solutions. Utilize formal problem- solving techniques to resolve product and/or process related issues.
• Write and or assist in development of protocols, technical investigation plans, engineering reports, and related procedures which ensure statistical validity, adequacy, and compliance to regulatory and corporate requirements.
• Working knowledge of concepts of probability and statistics as well as aide in updating/establishing SPC and Gage R&R studies.
• Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues.

The ideal candidate will possess the following Experience, Knowledge and Skills:

• 5+ years of work experience in the medical device industry.
• Experience with ISO 13485, and FDA 21 cfr part 820.
• Proficient computer skills (MS Office, Excel).
• Excellent verbal and written communication skills. Must be detail-oriented and able to work independently.

**Not able to provide sponsorship at this time