Sr. Manager Supplier Quality

Overview

At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients.

• Leading and managing all Supply Chain expectations end-to-end from a Quality perspective and in support of business needs.
• Monitors supplier performance to drive improvement and corrective action in the quality of materials / components sourced from suppliers; identify trends, drive corrective improvements, and report findings to management with quantified objectives.
• Evaluates supplier caused manufacturing yield issues, incoming quality issues, and field failures.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving the issues.
• Works cross-functionally in identifying and resolving technical issues.
• Plans and leads audits of suppliers to assess compliance with regulatory and Spacelabs requirements, including audit scheduling, investigation and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
• Assesses suppliers for technical, quality and manufacturing capabilities through direct on-site visits and technical discussions; assists in the evaluation of proposed changes at suppliers.
• Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
• Establishes and cultivates a wide range of business relationships to facilitate completion of assignments; interacts with suppliers; participates in determining goals and objectives for projects; may lead projects within the department.
• Facilitates and partners with suppliers to develop strong business and quality relationships ensuring strong communication and collaboration.
• Upholds the company’s core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrates behavior consistent with the company’s Code of Ethics and Conduct.
• Reports to manager or senior management any quality problems or defects in order to implement corrective action and avoid recurrence of the problem.
• Duties may be modified or assigned at any time to meet the needs of the business.

• Bachelor degree in Science or Engineering required.
• 8+ years of experience in manufacturing quality, engineering quality, or supplier quality (a combination of experience is acceptable).
• 5+ years of medical device industry experience.
• 3+ years of people management or team leadership experience, including goal setting, performance reviews, and employee development.
• Extensive knowledge of quality process management and tools (e.g. APQP, PPAP, SPC, process validation and verification, Statistics Tools and Analysis) in development and revision of Quality Sampling Plans based on potential product and patient risk.
• Applied experience with ISO 13485, FDA medical device regulations, cGMP, and Risk Management (ISO 14971) to instill a culture dedicated to ensuring patient safety and sustained regulatory compliance.
• Proficiency in data analysis, trending tools, and KPI/dashboard development; professional knowledge of statistical methods.
• Additional applied knowledge of international standards and regulations preferred.
• Strong technical written and verbal communication skills; ability to work effectively across all levels of a global organization and remain composed in stressful circumstances.
• Proficiency in multi-tasking and working in a high-paced, matrixed environment with an awareness of continued impact on compliance and operational performance.
• Ability to influence cross-functional teams, including Procurement / Supply Chain, Regulatory Affairs, Service and Research & Development to drive reduction in patient safety risk and greater levels of regulatory compliance.
• Organized and resourceful with excellent attention to detail and ability to execute on assigned project plans.
• Available for domestic and international travel up to 20%.

Pay may range between $165,000 - $185,000 annually. The pay range…