Senior/Principal Supplier Quality Engineer

Position Summary

MicroTransponder Inc. has developed the Paired Vagus Nerve Stimulation Platform (Paired VNS™ Platform), based on decades of neuroscience research. The Vivistim® System, for improving stroke survivors' hand and arm function, is the first FDA-approved system on the platform.

MicroTransponder Inc. is seeking a highly skilled and experienced Senior/Principal Supplier Quality Engineer (title commensurate with experience) to join our team. In this role, you will be pivotal in ensuring the quality and reliability of our suppliers, which is crucial for the continued success and innovation of our active implantable products. You will be responsible for evaluating, qualifying, and enhancing supplier performance, ensuring alignment with regulatory standards and our high-quality expectations.

Position Responsibilities / Essential Functions

• Supplier Management: Build and nurture strong relationships with key suppliers to ensure they meet our stringent quality expectations and regulatory requirements. Conduct thorough supplier audits, assessments, and performance reviews to identify and mitigate risks
  
  

A key responsibility is management of supplier change notifications/engineering change orders, with cross-functional collaboration across internal engineering and operations departments, and contract engineering & manufacturing partners.

• Quality Assurance: Oversee and refine supplier quality management processes, including supplier qualification, monitoring, and corrective actions. Ensure that suppliers adhere to FDA regulations, ISO 13485 standards, and other applicable requirements
• Risk Management: Identify potential risks associated with supplier processes and materials. Develop and implement effective risk mitigation strategies to ensure the safety and reliability of our products
• Continuous Improvement: Lead initiatives to drive continuous improvement within the supply chain. Analyze supplier performance data to uncover trends and areas for enhancement. Collaborate with cross-functional teams to resolve quality issues and implement best practices
• Documentation and Reporting: Maintain comprehensive documentation related to supplier quality activities, including audit reports, non-conformance reports, and corrective action plans. Provide regular updates and detailed reports on supplier quality metrics and performance to senior management
• Regulatory Compliance: Ensure all supplier activities comply with relevant regulatory requirements, including those specific to Class III medical devices. Stay informed about industry standards and regulatory changes to maintain compliance
• Training and Support: Provide training and support to suppliers and internal teams on quality standards, processes, and best practices. Serve as a resource for resolving complex quality issues and offering guidance on supplier-related matters
  
  
  

Requirements

QUALIFICATIONS

• Education: Bachelor's degree in Engineering, or a related field. Advanced degree or professional certification (e.g., CQE, CQM) preferred,
• Experience: 8 years of experience in supplier quality engineering in medical devices, with preference for experience within the Class III medical device sector and active implantable products. Proven experience with supplier audits, quality management systems, and regulatory compliance is essential
  
  
  

POSITIONAL COMPETENCIES

• Detail-oriented with a proactive approach to addressing quality issues.
• Demonstrated ability to manage multiple projects and priorities effectively
• Excellent analytical and problem-solving abilities
• Capable of working independently and as part of a team in a dynamic, fast-paced environment
• Outstanding communication and interpersonal skills, for positive working relationships and effective collaborations across internal functions and external vendors
• Strong understanding of FDA regulations, ISO 13485, and other relevant standards
• Understanding of the importance of good documentation, with an attention to detail and accuracy.
• Proficiency in quality management software and tools
  
  
  

PHYSICAL DEMANDS

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to reach; talk or hear in a standard office environment. Employee must possess the ability to lift, carry, push, and pull materials and objects weighing up to 40 pounds and heavier weights with the proper equipment. Ability to work after hours as required by business issues.

MicroTransponder, Inc. is an equal opportunity employer. MicroTransponder, Inc. is committed to equal treatment and opportunity in all aspects of recruitment, selection, and employment without regard to gender, race, religion, national origin, ethnicity, disability, gender identity/expression, sexual orientation, veteran or military status, or any other category protected under the law.

Benefits

MicroTransponder provides a comprehensive benefits program to employees. It includes medical, dental and vision plans along with an FSA. Employees may participate in the company 401(k) plan with company matching. The company offers an unlimited Paid Time Off (PTO) program and approximately 15 paid company holidays per year.