Sr. Manager Quality

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 Senior Quality Assurance Manager manages quality system processes, internal audits, corrective action preventive action (CARs and PARs), change control, quality system software validations and the quality system training program. These activities include ensuring compliance to applicable standards and regulations associated with these functional areas, process development and maintenance, and employee development and management.

• Drive improvement of Key Performance Indicators (KPI’s) related to the department and company quality objectives.
• Establishes and maintains quality programs and systems to support corporate quality policy, regulatory requirements, and quality objectives.
• Manage the quality management system for our medical device products and maintain its effectiveness and improvements in eQMS systems.
• Provide QMS support and guidance for new products and product maintenance.
• Create and update quality system procedure to achieve continuous compliance to FDA QSR, ISO
  13485, European MDD, MDSAP and Canadian regulatory requirements.
• Assures the quality assurance programs and policies are maintained and modified regularly to meet global company growth plan.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
• Support external audits and supports communication with foreign regulatory sponsors for global regulatory approvals.
• Functions as the Spacelabs Device Master Record owner.
• Establishes and maintains Corrective Action and Preventive Action management systems to ensure that all CAPA’s are assigned.
• Ensure timely and effective maintenance of the Corrective Actions and Preventive Actions including CAPA logs.
• Ensure substantial Quality Assurance employee ownership and completion of CAPA activities.
• Manages conformity assessment audits of policies, procedures and quality systems to identify non-conformities and ensure prompt and effective corrective actions are accomplished.
• Establishes and maintains the management of the Internal Quality Audit (IQA) system.
• Establishes and maintains a dashboard of current status.
• Develop a team of Internal Quality Auditors across the RA/QA organization.
• Audit checklists are produced.
• Review of audit reports prior to Issue.
• Review and approval of corrective actions prior to closure.
• Facilitate basic IQA training of all audit staff, including Checklist preparation, documenting findings, final audit reporting, change order validation, and audit corrective action.
• Team leader who supports a high performing culture with mixed onsite, hybrid and remote team members supporting the global QMS system.
• Builds a high-performance team through recruiting, mentoring, leading, and assisting team members with career and performance development.
• Establishes group goals and objectives as well as cross-functional goals and objectives; ensures progress towards goals is met.
• Manages Spacelabs configuration control system and change control processes.
• Manages quality system computerized software validation(CSV).
• Establishes and maintains a CSV process.
• Validation a gap list of QMS software that has not been validated.
• Ensure…