Paul, MN

Duration: 12 Months

Note: No C2C

Job Summary:

The Senior Development Quality Engineer will play a critical role in the design, development, and commercialization of medical devices. The role focuses on ensuring compliance with regulatory standards and driving product quality throughout the product lifecycle. The ideal candidate will work closely with cross-functional teams to ensure robust design, risk management, and process validation while meeting regulatory and quality requirements.

Key Responsibilities:

Design and Development:

• Partner with R&D to develop and implement quality engineering practices in the product development process.
• Ensure design control activities are executed in compliance with FDA QSR, ISO 13485, and other applicable standards.
• Participate in design reviews to ensure product requirements are well-defined, risk is minimized, and quality is built into the design.

Risk Management:

• Perform and oversee risk management activities, including FMEA (Design and Process), risk analysis, and hazard assessments.
• Support the development and maintenance of risk management files in compliance with ISO 14971.

Testing and Validation:

• Review and approve test protocols, reports, and validation activities for design verification, validation, and process validation.
• Collaborate with test labs to ensure product testing meets regulatory and quality requirements.
• Investigate and resolve testing failures, ensuring root cause analysis and corrective/preventive actions are implemented.

Regulatory Compliance:

• Ensure compliance with global regulatory requirements, including FDA, EU MDR, and ISO standards.
• Support regulatory submissions by providing quality documentation and data.
• Act as the quality representative during audits and inspections, providing support for inquiries related to design and development activities.

Process Improvement and Documentation:

• Develop and improve quality procedures and processes to enhance efficiency and compliance.
• Generate and maintain technical documentation, including Design History Files (DHFs) and Device Master Records (DMRs).
• Provide input on manufacturing processes to ensure product quality during scale-up and commercialization.

Cross-Functional Collaboration:

• Collaborate with cross-functional teams, including R&D, manufacturing, regulatory, and supply chain, to ensure seamless product development.
• Provide training and guidance to team members on quality and compliance topics.
• Lead or support CAPA initiatives and change control processes related to product development.

Supplier and Component Quality:

• Oversee supplier quality activities, including qualification and monitoring.
• Review and approve incoming inspection criteria and work with suppliers to resolve quality issues.

Required Qualifications:

• Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or a related field).
• 5+ years of experience in quality engineering, with a focus on medical device development.
• Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and EU MDR.
• Experience with design controls, risk management, and product validation.
• Proficiency in root cause analysis, statistical techniques, and quality tools (e.g., Minitab, Six Sigma).
• Excellent written and verbal communication skills.
• Experience with regulatory audits and inspections is a plus.

Preferred Qualifications:

• Advanced degree in Engineering or a related field.
• Certified Quality Engineer (CQE) or Six Sigma certification.
• Experience with electromechanical or software-driven medical devices.
• Familiarity with design transfer and manufacturing quality systems.