Field Quality Leader

Overview

At Spacelabs Healthcare, you make a difference.

Every member of our worldwide team plays an integral role in improving treatment and helping providers deliver exceptional care to their patients. From newborns to centenarians, more than 60 million people benefit each year from the advancements we make in patient monitoring and management, care coordination, and clinical decision support.

Driven by the belief that anyone who seeks care could be a member of our own family, our team is dedicated to solving the greatest challenges the healthcare system currently faces, including the need to enhance patient experience, improve population health, reduce costs, support care team well‑being, and advance health equity. As part of our mission, we take pride in creating services and technologies that are personalized and tailored to support the needs of healthcare providers anywhere in the world.

Because while we may not be at a patient’s bedside, their health is still in our hands.

This is a remote position with up to 40% travel required.

• Responsible for the effective and efficient operation of the Sales and Service subsystems of the Spacelabs Quality Management System.
• This includes overseeing all aspects of installation, implementation, servicing, complaint handling, product performance measurement and trending, and recall‑related activities.
• Recommend and implement corporate global strategy to establish, improve, and maintain intended operation of Sales and Service functions under the QMS.
• Ensure Spacelabs quality management system Sales and Service subsystems are compliant with 21 CFR 820, ISO 13485, ISO 14971, Canadian Medical Devices Regulation, EU Medical Device Regulation, and other foreign country requirements, as required.
• Facilitate and ensure adequate staff competency and training to perform required roles and responsibilities.
• Support internal and external audits to ensure subsystem compliance and adequacy of performance.
• Assess and investigate Quality Problems, Identify Root Cause, and execute relevant corrective action to address substantial nonconformance, noncompliance, and other Quality Problems that may affect performance.
• Identify, measure, and ensure intended QMS subsystem performance, based upon KPI’s and OKRs.
• Ensure functional compliance with Occupational Health and Safety and Environmental Management System requirements.
• Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrate behavior consistent with the company’s Code of Ethics and Conduct.
• It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
• Duties may be modified or assigned at any time to meet the needs of the business.

• Bachelor's degree or higher in a scientific discipline.
• 15+ years of combined experience showing increased responsibilities within quality management and/or field service.
• 5+ years' experience within the medical device industry.
• Experience leading successful transformations and/or field quality organizations.
• Strong knowledge of global medical device regulations (including: 21 CFR Part 820 Quality System Regulation and relevant sub parts, ISO 13485, ISO 14971, MDSAP, EU MDR, ANVISA, etc.).
• Experience in indirect and influence management as well as a track record of hands‑on effort.
• Ability to manage multiple, complex priorities within demanding time frames. Strong project management skills.
• Process driven. Can train and manage an organization to follow processes consistently.
• Experienced user in Microsoft Office, eQMS, and database usage required.
• Strong presentation and communication skills. Effective communicators from field technicians to leadership to customers to regulators.
• Experience working positively and productively in a team environment. Highly collaborative. Can build trust.
• Proven ability to deliver results through others, both direct and matrixed. Proven ability to lead, develop, motivate, and hold others accountable.
• Proven ability to embrace change and to participate in…