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Spacelabs | Filing | Relocations | Installations · 1 week ago

QMS Remediation Project Manager

Snoqualmie, WA

Full-time

Onsite

Senior Level

6+ years exp

Spacelabs Healthcare is dedicated to improving patient care through innovative solutions. The Quality Management System Remediation Project Manager will lead the QMS Remediation program, collaborating with cross-functional teams to ensure compliance and effective project execution.

Facilities Support ServicesFurnitureTransportation

No H1B

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

Qualification

Quality Management SystemsMedical Device RegulationsProject ManagementMicrosoft OfficeTeam LeadershipCommunication SkillsTime ManagementCollaboration

Required

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)