Manager Quality Systems

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.

The Quality Systems Manager is responsible for managing all facets of quality assurance, including ownership of the Quality Management System (QMS) for the company. The primary focus is to ensure that the QMS and all aspects of quality assurance activities are compliant with U.S. FDA, ISO, and MDR Standards and Regulations for Medical Devices.

The Quality Systems Manager manages quality system administration, internal audits, corrective action, and preventive action (CARs and PARs), operational change control, quality system software validations, and the quality system training program.

• Establish and manage the maintenance of the Spacelabs Quality Management System.
• Establish and maintain quality programs and subsystems to support corporate quality policy, regulatory requirements, and quality objectives.
• Manage control of Quality Management System changes.
• Manage the document control process.
• Ensure staff training and competency to ensure adequate and effective QMS performance.
• Facilitate company operational change control systems:
  Corrective Action, Preventive Action, Process Change Control, and Exception Handling.
• Create and update quality system procedures to achieve continuous compliance with the FDA Quality System Regulation, ISO
  13485, European MDR, MDSAP, and Canadian regulatory requirements.
• Ensure and support assessment of QMS performance with key performance indicators and quantifiable quality improvement objectives.
• Manage internal audits of policies, procedures, and company activities to ensure compliance with regulations, standards, and Spacelabs QMS.
• Support external audits and communications with foreign regulatory sponsors for global regulatory approvals.
• Build a high‑performance team through recruiting, mentoring, leading, and assisting team members with career and performance development.
• Establish group goals and objectives as well as cross‑functional goals and objectives; ensure progress towards goals.
• Ensure timely and effective validation of QMS Software (Computer System Validation).
• Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. Ensure that direct report(s) are trained and evaluated on their knowledge and adherence to the Company’s values, Code of Ethics and Conduct, and applicable compliance policies.
• Hire, manage, evaluate, and develop a team of employees to meet functional deliverables and responsibilities. Completes the company people management requirements. Exhibits the manager's core competencies.
• 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 Spacelabs Healthcare 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 in business, sciences, quality management, related field, or additional equivalent professional experience.
• 10+ years of Quality Assurance experience in…