Senior Quality Engineer

Jobtailor; Chaska (MN); On-site; USD 110,000 - 140,000; Full time

Job summary

Jobtailor in Minnesota seeks a seasoned regulatory/compliance engineer to lead medical device quality activities. You will interpret FDA/MDSAP/ISO standards, guide design changes, author SOPs, and prepare for audits within a cross-functional team.

The role requires 5+ years in engineering or quality and deep knowledge of ISO 14971 and ISO 62304, with the ability to read and interpret engineering drawings and advise senior leadership on regulatory requirements.

Qualifications

• BS in engineering required.
• 5+ years in engineering or quality.
• Experience with FDA inspections, MDSAP audits, ISO 13485 audits.
• Knowledge of ISO 14971 and ISO 62304.
• Ability to read and interpret engineering drawings.
• Ability to advise senior leadership on regulatory requirements.

Responsibilities

• Analyze medical device products for compliance to standards.
• Participate in the Design Change process.
• Author new SOPs and other documentation.
• Review and approve COs, NCRs, CAPA records.
• Work with cross-functional team to support product development.
• Perform Design History File audits.
• Provide compliance guidance concerning development, application, and maintenance of quality standards.
• Prepare, support, and ensure readiness for audits and inspections.

Skills

Audit experience

Regulatory guidance

Cross-functional collaboration

Reading drawings

Education

B.S. in Engineering

Job description

Responsibilities

• Analyze medical device products for compliance to standards
• Participate in the Design Change process
• Author new SOPs and other documentation
• Review and approve Change Orders (COs), Nonconformance Report (NCRs), Corrective and Preventive Action (CAPA) records
• Work within a cross-functional team to support product development
• Perform Design History File audits
• Provide compliance guidance concerning development, application, and maintenance of quality standards
• Prepare, support, and ensure readiness for audits and inspections

Requirements

• Bachelor of Science (B.S.) degree or higher in engineering
• At least 5 years of experience in engineering or Quality
• Direct experience with FDA inspections, MDSAP audits, ISO 13485 audits
• Experience advising senior leadership and applying pre/post market regulations
• Knowledge of ISO 14971 Risk Management standard
• Knowledge of ISO 62304 Life Cycle Requirements for Medical Device Software
• Knowledge of Medical Electrical Equipment Safety Standards
• Ability to read, analyze and interpret engineering/technical drawings