Production Quality Engineer

The role

The Production Quality Engineer establishes, maintains, and improves quality systems and production quality processes for medical device manufacturing. This role focuses on ensuring compliance with ISO 13485 and FDA QMSR requirements while performing hands-on problem solving on the production floor.

What you will do

• Develop, implement, and maintain quality system processes aligned with ISO 13485:2016 and FDA QMSR / 21 CFR Part 820
• Author and maintain quality documentation including SOPs, work instructions, forms and records
• Support compliance of a predominantly electronic QMS
• Support annual FDA establishment registration and device listing activities
• Support internal audits and external audits
• Investigate nonconforming product and process deviations
• Lead and support CAPA activities including root cause analysis and effectiveness verification
• Work directly with production and technicians to investigate product and process issues
• Develop, execute, and maintain IQ/OQ/PQ validation activities
• Support risk management activities aligned with ISO 14971

Benefits

• medical, dental and vision coverage
• 401k plan with employer contribution
• paid holidays
• vacation
• tuition reimbursement

About the company

blackcanyonconsulting is a high performing, professional service and technology focused organization.