QMS Remediation Project Manager

OSI Systems, Inc•Snoqualmie, WA

23h

About The Position

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 the 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 Management System Remediation Project Manager is responsible for leading, developing, facilitating, tracking, and reporting on the results of the QMS Remediation program. The QMS Remediation Project Manager shall work closely with functional management, cross-functional teams, and RA/QA to prepare comprehensive action plans, monitor and update project progress, assess and report on company resources and timeframes, execute action plans, and report progress to functional and executive management. He or she shall manage specific project tasks, such as managing a schedule, performing administrative duties, including reporting and escalation to resolve outstanding actions, and following up on due or late project deliverables.

Requirements

Bachelor's degree in a technical, legal, or quality engineering discipline with 8 years of equivalent experience; or Master’s degree or higher in a technical, legal, or quality engineering discipline with 6 years of equivalent experience.
6+ years' quality experience within the medical device industry.
6+ years’ experience leading successful projects, including company-wide remedial efforts, through successful completion.
Exhibits advanced, wide-ranging experience, using in-depth professional knowledge, acumen, concepts, and company objectives to develop, resolve complex models and procedures.
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, etc.).
Proven ability to deliver results through others, both direct and matrixed. Proven ability to lead, develop, motivate, and hold others accountable at all levels and functions of the organization.
Networks with key contacts at all levels of the organization outside own area of expertise. Adapts style and uses persuasion in delivering messages that relate to the wider firm's business.
Ability to manage multiple, complex priorities within demanding timeframes. Strong project management skills.
Process driven. Can train and manage an organization to follow processes consistently.
Advanced user in the Microsoft Office platform, as well as project management and management-level presentation applications.
Strong presentation and communication skills. Effective communicators from field technicians to leadership to customers to regulators.
Experience working positively and productively in a collaborative team environment.
Understands and works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Determines methods and procedures for new assignments. Exercises judgment in selecting methods, evaluating, and adapting complex techniques and evaluation criteria for obtaining results.
Excellent time management and communication skills, including the ability to concurrently manage and facilitate a high number of project tracks and teams.
Proven ability to embrace change and to participate in change management in a company leadership role.
Must be able to complete responsibilities working with global time zones, such as attending late-night/early morning meetings by phone and/or web to meet global business needs.
Must be able to work in the U.S. without visa sponsorship (e.g., H-1B visa status).

Responsibilities

Leads quality management system remediation, driving corporate culture change, securing management and employee participation and buy-in, and ensuring effective and timely completion of remediation projects and activities.
Develop, manage, and facilitate project support, expectations, schedules, charters, action plans, metrics, and reporting, and other appropriate project management tools. Implement QMS remedial activities.
Lead functional and cross-functional teams to meet project requirements and deadlines.
Monitor, track, and control outcomes to resolve issues, conflicts, dependencies, and critical path deliverables.
Complete and publish metrics for project tracking to measure and communicate program status via cross-functional team, functional, and management dashboards and presentations.
Support the development of solutions by providing coaching and, at times, challenging perspectives to achieve necessary outcomes for QMS remediation.
Establish, maintain, update, and close corrective actions, preventive actions, process change orders, exception handling reports, and other relevant QMS administrative plans and change orders.
Ensure Spacelabs quality management system 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.
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.
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.