Design Quality Engineer

Roles and Responsibilities

• Be a subject matter expert in Design Control regulations and applicable standards.
• Develop and manage design and development quality systems, and provide direction, support, and oversight of the program.
• Ensures building compliant new product development processes with adherence to FDA Design Control requirements and Risk Management ISO standards.
• Perform a review of design projects and design control procedural deliverable requirements.
• Participate in risk assessments, risk mitigation strategies and risk management plans, provide review/approval as needed.
• Provide design control lifecycle, procedure, and policy training.
• Support product design related investigation of quality events such as nonconformities, CAPAs, customer complaints, etc.
• Serves as Quality lead on design change control submissions.
• Author and review Design Control documentation to support regulatory filings.
• Determine compliance of processes and regulations.
• Supports efforts to ensure the organization operates within established policies/procedures and complies with all applicable governmental regulations, both domestic and foreign.
• Affiliate during audits in the room (supplier, critical supplier, notified body, or otherwise).

Required Qualifications

• Bachelor's degree from an accredited university or college.
• At least 6 years of relevant experience in Quality Assurance in a regulated industry, either Medical Devices or Pharmaceuticals, preferably with Software as a Medical Device (SaMD).
• Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements, including but not limited to FDA CFR 21 820, ISO 13485, and MDSAP.
• Legal authorization to work in the U.S. is required.

Desired Characteristics

• Experience in Quality Assurance or Quality Engineering within the Medical Device or Pharmaceutical industry, or in Design Engineering in the Software as a Medical Device field (SaMD).
• Demonstrated expertise in Medical Device Design Controls, Production and Process Controls, and Installation and Servicing.
• Strong influencing skills and ability to clearly communicate the requirements of Design Controls, Design Verification and Validation, Production and Process Controls, Corrective & Preventive Action (CAPA), and Risk Management across functions.
• Demonstrated ability to collaborate effectively and resolve conflicts.
• Capability to lead, develop, communicate, and implement compliance goals during crises.
• Exceptional critical thinking, problem-solving, root-cause analysis, and process improvement skills.
• Proficiency in managing multiple priorities effectively.