Project Manager, Quality & Continuous Improvement

Endologix

22h•Hybrid

About The Position

We're looking for a Project Manager, Quality & Continuous Improvement to lead cross-functional projects in a highly regulated medical device environment, with primary responsibility for eQMS implementation and execution of continuous improvement initiatives. This role ensures projects are delivered on time, within scope, and within budget, while meeting applicable quality and regulatory requirements.

Requirements

Bachelor’s degree or equivalent experience desired.
5+ years of project management experience delivering projects on time and within budget. Experience having managed and delivered on an eQMS project preferred.
Demonstrated experience leading cross-functional teams in regulated or highly controlled environments.
Project Leadership Focused on Patient Outcomes – Proven ability to lead complex, cross-functional quality and systems initiatives from initiation through sustainment, ensuring projects strengthen the quality system and ultimately improve patient outcomes.
Integrity & Quality-First Mindset – Demonstrates transparency, accountability, and sound judgment in all project decisions; prioritizes compliance, documentation accuracy, and audit readiness while consistently doing what’s right.
Innovation & Continuous Improvement – Applies Lean, Six Sigma, and structured problem-solving methodologies to enhance QMS effectiveness, drive efficiency, and push boundaries in pursuit of operational excellence.
Bold, Strategic Execution – Confidently navigates ambiguity and regulatory complexity, takes smart, well-informed risks, and drives initiatives forward with resilience and ownership.
Change Management Leadership – Serves as a proactive change leader, guiding teams through system and process transformations with clear communication, strong stakeholder engagement, and sustained adoption.
Collaboration & Stakeholder Partnership – Builds trusted partnerships across Quality, Regulatory, IT, Operations, Manufacturing, and external stakeholders, fostering alignment and shared accountability to deliver exceptional results.
Regulatory & QMS Expertise – Strong understanding of FDA, ISO 13485, and applicable global regulatory requirements, with the ability to translate expectations into compliant, scalable processes within an eQMS environment.
Risk Management & Data-Driven Decision Making – Proactively identifies and mitigates risks using structured methodologies; leverages metrics, KPIs, and trend analysis to inform decisions and continuously elevate performance.
Communication & Executive Influence – Strong written and verbal communication skills with the ability to clearly articulate complex concepts, provide transparent project reporting, and influence leadership and cross-functional teams.
Organizational Excellence & Accountability – Highly organized with disciplined planning and documentation practices; manages competing priorities while maintaining focus on timelines, budgets, and quality deliverables.
Technical & Systems Proficiency – Experienced in eQMS platforms, ERP systems, and project management tools (e.g., MS Project, Smartsheet, Jira) to enable efficient execution and visibility.

Responsibilities

Lead end-to-end eQMS implementation, driving advancements that strengthen our quality systems and ultimately improve patient outcomes, including planning, execution, risk management, and change control.
Manage cross-functional project teams with integrity and transparency, fostering accountability to defined deliverables and timelines while ensuring quality remains a top priority.
Collaborate closely with stakeholders across Quality, Regulatory, IT, Operations, and Manufacturing—partnering effectively to gather requirements, align priorities, and deliver exceptional results.
Track and manage project schedules, budgets, risks, and dependencies with ownership and accountability; proactively communicate status, challenges, and solutions to leadership.
Champion innovation by leading continuous improvement initiatives that enhance QMS effectiveness, efficiency, and compliance within an evolving regulatory landscape.
Ensure all project documentation and deliverables are compliant, controlled, audit-ready, and reflective of our commitment to integrity and quality.
Navigate and apply regulatory expectations within a medical device quality system with boldness and sound judgment, taking smart, well-informed risks to drive excellence.
Remain adaptable and responsive, performing other duties as assigned in support of team objectives and organizational success.

Benefits

Base salary of $141,395/yr-$171,514/yr
Discretionary bonus
Equity participation as approved by Board of Directors (4-year vesting schedule)
Comprehensive health, dental, and vision insurance plans
Flexible Health Savings Accounts (HSAs) and/or Flexible Spending Accounts (FSAs)
Generous paid time off (vacation, sick leave, holidays, and flexible time off that is available for Exempt employees)
401(k) retirement plan with company match
Flexible work arrangements, such as hybrid or remote work for many of our positions
Employee wellness initiatives, mental health resources, and Employee Assistance Program (EAP)
Employee recognition programs and awards
Commuter benefits or transportation stipends