Supplier Quality Engineer

Job Description

The Supplier Quality Engineer will provide Supplier Quality support and oversight to client locations as part of the UDI program. This individual will be responsible for leading the global UDI implementation with suppliers to ensure that the processes implemented at the supplier’s manufacturing locations are compliant with FDA UDI requirements. They must have knowledge of the UDI regulation and be responsible for setting the strategy on how it will be implemented at all manufacturing locations.

The Supplier Quality Engineer must have some knowledge of manufacturing processes, applications, and process development. The ability to effectively collaborate, influence, and coordinate among suppliers and team members within sourcing, materials management, design engineering, receiving inspection, and quality management at various sites is critical to this role.

• Understand Quality System requirements and adhere to procedures and instructions.
• Work with UDI Core Team to develop corporate UDI process.
• Interface with supplier’s engineering and quality organizations to efficiently develop new processes to implement the requirements of the UDI regulation.
• Perform evaluations of supplier’s quality systems and manufacturing processes to assess supplier’s capabilities to implement UDI requirements, and develop and implement supplier risk mitigation plans when appropriate.
• Train suppliers to develop their knowledge of UDI requirements.
• Work with suppliers to address reported problems impacting functionality, quality, and regulatory requirements; drive corrective and preventive actions at the supplier to preclude recurrence of identified issues.
• Measure and communicate to management global supplier progress in implementing UDI requirement.
• Escalate issues to management as appropriate.
• Must be willing and flexible for business travel as required (supplier visits), travel required may be upwards of 30%.

• Bachelor of Science in Engineering or related technical field required (Mechanical, Electrical, or Biomedical preferred).
• 2+ years of manufacturing, quality assurance, and/or engineering experience required.
• Working knowledge of US medical device regulations (21 CFR Parts 820, 803, and 806) required.
• Working knowledge of standard quality system requirements (ISO 9001, ISO 13485, Medical Device Directive, Canadian Medical Device Regulation) preferred.
• Practical knowledge of FDA UDI regulation preferred.
• Supplier quality experience in medical device or related GMP environment preferred.
• Ability to operate independently, communicate effectively, and successfully manage multiple responsibilities required.
• Leadership skills with a passion to embrace positive change for ongoing operations and new initiatives required.
• Fluency in English language required.

All applicant information will be kept confidential according to EEO guidelines.