Sr. Design Control Quality Engineer (ISO 13485)

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Job Overview

Infosoft, Inc. is seeking a highly skilled Senior Design Control Quality Engineer with expertise in ISO 13485 regulatory requirements to strengthen our quality management systems in the design and development of medical devices. The successful candidate will be responsible for leading quality assurance efforts, ensuring compliance with regulatory standards, and facilitating cross-functional collaboration for continuous improvement and innovation within our engineering teams. This role requires a proactive and detail-oriented professional who can oversee design controls from conception through production, while driving a culture of quality and excellence throughout the organization.

Job Responsibilities

• Develop and implement design control processes in accordance with ISO 13485 standards.
• Conduct risk assessments and ensure that risk management practices are integrated into the design and development phases.
• Review and approve technical documentation, including design inputs, outputs, verification and validation plans, and design transfer records.
• Lead internal and external audits to evaluate compliance with applicable regulatory and quality standards.
• Facilitate training and mentorship programs to elevate quality awareness among staff and stakeholders.
• Collaborate with cross-functional teams to analyze design changes and assess their impact on product quality and safety.
• Implement corrective and preventive actions (CAPA) related to design control issues, ensuring timely resolution and documentation.
• Prepare and present quality metrics and reports to senior management, highlighting areas for improvement and action plans.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related field; Master’s degree preferred.
• Minimum of 5 years of experience in quality engineering, particularly within the medical device industry.
• Strong knowledge of ISO 13485, FDA regulations, and international quality standards.
• Proficient in quality tools and methodologies, including root cause analysis and statistical process control.
• Demonstrated experience in leading design control and risk management activities.
• Excellent interpersonal and communication skills, with the ability to work effectively across various teams.
• Strong analytical and problem-solving skills, with a keen attention to detail.

Technologies & Tools

The Senior Design Control Quality Engineer will utilize various technologies and tools to perform their duties effectively. This includes quality management system software such as MasterControl or TrackWise, document management systems, and statistical analysis tools like Minitab. Proficiency in Microsoft Office Suite is expected, as well as familiarity with design tools such as CAD software for reviewing engineering designs.

Ideal Candidates

Ideal candidates for the Senior Design Control Quality Engineer position will possess a strong commitment to quality and safety in the medical device industry. They should demonstrate a proactive mindset towards problem-solving and have the ability to think critically under pressure. Successful candidates will also exhibit effective leadership qualities, fostering collaboration among team members and stakeholders. A passion for continuous improvement and staying abreast of industry standards will further distinguish exceptional candidates for this role.