Job Summary:

Exo-Imaging is seeking a full time Senior Supplier Quality Engineer to work onsite at least 3 days a week as Exo’s Quality representative in relationship with Exo Imaging’s supplier base, facilitating product development, design transfer, manufacturing process improvements and cost reduction projects.

Job Responsibilities:

• Manage ASL, develop supplier qualifications, and drive supplier quality performance.
• Work closely with Contract Manufacturers to ensure products and assemblies are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.
• Develop and report supplier performance metrics and monitor suppliers’ performance.
• Review product specifications. Support the establishment of attributes critical to quality.
• Coordinate qualification plans for new parts, PFMEAs, and process validations with critical vendors.
• Determine the cause of supplier quality issues and coordinate/implement improvement plans.
• Conduct supplier audits.

Education/Experience Requirements:

• BS degree in Life Sciences with a minimum of 5 years of experience in medical device manufacturing and product development.
• Experience with wafer manufacturing, PCBA, and manufacturing of electronic devices
• Good understanding of GD&T and statistical analysis.
• Must be able to make technical decisions independently, provide technical guidance to suppliers and other team members and assume high levels of responsibility. Must have strong knowledge of medical device GMPs, ISO 13485, and ISO 14971.
• Experience in Quality Control and/or Receiving Inspection.
• Excellent communication and presentation skills are required.
• Experience in new product development and launch activities.

Other Requirements:

• Good command of Mandarin highly preferred.
• Available to travel up to 40% of the time, mostly to Asian (Taiwan) suppliers.
• Supervision of other employees is not required.