The Supplier Quality Engineer position is within the Infectious Disease Developed Markets business unit. This role is crucial in ensuring that all purchased or otherwise received materials, products, and services impacting the quality of products or services provided conform to predefined requirements and quality attributes. The job description is subject to periodic review and change by management.

Responsibilities:

• Maintain the Supplier Quality function by working closely with and supporting Purchasing, New Product Development, and Engineering teams.
• Respond promptly and professionally to internal and external supplier requests related to quality.
• Manage supplier changes through the change management system.
• Review Supplier Validation Protocols to ensure they meet regulatory and customer requirements.
• Collaborate with the engineering team to schedule, drive, and review purchased product first article inspections, capability studies, and gage R&Rs.
• Conduct root cause analysis of product quality issues and defects for new and sustaining purchased products, implementing solutions to resolve issues. Assist with the Corrective Action process specific to purchased components and services as needed.
• Manage the Supplier Corrective Action process and drive improvement to the Approved Supplier List (ASL).
• Utilize supplier scorecards/metrics and analytical tools to quantify supplier performance levels, and work with suppliers to develop improvement plans to achieve quality performance goals.
• Establish and execute priorities to meet expectations.
• Identify and implement continual improvement opportunities to streamline quality systems and processes.
• Perform external audits as required, based on the published audit schedule or if suppliers are struggling to achieve established quality metrics.
• Perform other duties as required.

Basic Qualifications:

• BS in Engineering, Manufacturing, Biology, or a related discipline, or equivalent combination of education and experience.
• 2+ years of experience in the medical device industry, preferably in Quality or Supplier Engineering.
• Demonstrated proficiency in Microsoft Word, PowerPoint, and Excel.

Preferred Qualifications:

• Familiarity with federal and other regulations, such as QSR’s, ISO 13485, CMDR, IVDD/IVDR.
• Working knowledge of the General Provisions of 21 CFR Part 11 for Electronic Records and Electronic Signatures.
• High level of proficiency in Microsoft Office Suite applications.
• High level of attention to detail and accuracy.
• Strong organizational skills and the ability to prioritize tasks.
• Exceptional documentation and technical writing skills.
• Excellent verbal and written English language skills.
• Ability to establish and maintain strong, effective working relationships with internal employees and external customers.
• Ability to react quickly and adapt to changes in priorities, circumstances, and direction.
• Independent reasoning ability and the capacity to work with minimal supervision.
• Ability to interpret data and make sound judgments based on those interpretations.
• Must be able to adapt to quickly changing priorities and schedules.
• Ability to maintain good working relationships with all co-workers and external contacts.