Senior Supplier Quality Engineer

Responsibilities

• Act as the primary operational contact for contract manufacturers and serve as the main point of coordination for day-to-day operations.
• Partner closely with contract manufacturers to identify, investigate, and resolve manufacturing issues in a timely and effective manner.
• Cook directly with internal Quality and Engineering teams to align supplier activities with internal requirements and standards.
• Manage supplier performance across quality, delivery, and cost metrics, and drive corrective and preventive actions when performance gaps arise.
• Provide sustaining engineering support, including performing root cause analysis, executing corrective and preventive actions (CAPA), and supporting Material Review Board (MRB) activities.
• Lead supplier-related projects such as process transfers, IQ/OQ/PQ validations, and capacity expansions to support business growth and continuity.
• Support new product introduction (NPI) by contributing to supplier selection, developing requests for quotation (RFQ), and planning manufacturing readiness.
• Drive quality improvement initiatives with suppliers and participate in supplier compliance activities to maintain adherence to FDA, ISO, and internal quality system requirements.
• Collaborate across Quality, Research and Development (R&D), and Supply Chain functions to ensure cohesive planning and execution of supplier-related activities.
• Ensure supplier processes and documentation align with Device Master Records (DMR) and other manufacturing documentation requirements.
• Support remediation and continuous improvement efforts within supplier quality to strengthen overall supply chain robustness.

Requirements

• Experience working in medical device or regulated manufacturing environments, including familiarity with FDA and ISO requirements.
• Strong understanding of Device Master Records (DMR) and associated manufacturing documentation.
• Hands-on experience with manufacturing engineering activities such as injection molding, assembly, or electro-mechanical systems.
• Proficiency in root cause analysis and structured problem-solving methodologies.
• Experience working within a Quality Management System (QMS) in a regulated industry.
• Experience supporting new product launches and production transfers in a manufacturing environment.
• Strong ability to communicate effectively with suppliers, cross-functional teams, and executive stakeholders.
• Proven track record of improving supplier quality and on-time delivery performance.
• Project management skills and cross-functional leadership capabilities.