Senior Quality Design Assurance Engineer, Med Devices

Jobtailor; Fridley (MN); On-site; USD 120,000 - 160,000; Full time

Job summary

Jobtailor is seeking an experienced Quality Assurance Engineer to lead QA activities on complex medical device components in Minnesota. You will represent QA on development projects and ensure compliance with regulatory standards.

Responsibilities include supporting design controls, risk management, V&V, inspection planning, and nonconforming product dispositions. Travel between Fridley and White Bear Lake is expected.

Qualifications

• Bachelor’s degree in engineering or related field required.
• Minimum 8 years of relevant experience; 1 year may be substituted for graduate degree or 3 years for doctorate.
• Experience in the medical device industry as a Quality Assurance Engineer strongly preferred.
• Practical experience and familiarity with ISO 13485, FDA QSR, Design Controls, GMP, GLP, ISO 14971, sterilization, cleanrooms, and related standards.
• Customer-focused mindset with collaborative working ability.
• Must be highly organized and able to manage multiple projects concurrently.
• Strong written and verbal communication skills.
• Must be willing and able to travel between Fridley, MN and White Bear Lake, MN.

Responsibilities

• Lead project team members supporting the development of complex medical device components.
• Represent the Quality Assurance function on multiple product and process development projects.
• Ensure development activities comply with regulatory requirements, customer requirements, and quality standards.
• Support design controls, risk management, verification and validation activities.
• Design and specify inspection strategies, test plans, and procedures.
• Initiate, review, and approve Nonconforming Product dispositions; perform root-cause analysis.
• Lead continuous improvement initiatives, proposing solutions and improving product quality.
• Support and interface with engineering, manufacturing, regulatory, quality, and operations teams.
• Facilitate customer audits and ensure readiness for regulatory audits.
• Provide mentorship and technical guidance to junior engineers.

Skills

Quality Assurance

Root-Cause Analysis

Project Management

Regulatory Compliance

Risk Management

Continuous Improvement

Team Collaboration

Communication Skills

Organizational Skills

Travel Readiness

Education

Bachelor degree in engineering or related field

Tools

Microsoft Word

Microsoft Excel

Minitab

Job description

Jobtailor is seeking an experienced Quality Assurance Engineer to lead QA activities on complex medical device components in Minnesota. You will represent QA on development projects and ensure compliance with regulatory standards.

Responsibilities include supporting design controls, risk management, V&V, inspection planning, and nonconforming product dispositions. Travel between Fridley and White Bear Lake is expected.