Program Manager IV, Med-Device

Actalent Services (formerly EASi LLC) is hiring an experienced Program Manager for a key leadership role overseeing our Quality Assurance (QA) projects for a strategic M&A initiative in the medical device industry. This role will interface with client stakeholders as well as direct an Actalent Project Manager overseeing Regulatory Affairs (RA) and Clinical Affairs (CA), and work both independently and in coordination with the R&D Program Manager. The position requires full-time onsite presence (5 days/week) in Irvine, CA and requires a strong leader with deep industry expertise and exceptional cross-functional collaboration skills.

Responsibilities

• Assemble and lead project teams, assign responsibilities, and identify resources to ensure timely project completion.
• Capture detailed customer requirements, constraints, and assumptions to define project deliverables.
• Develop strategy and planning documentation.
• Estimate, monitor, and manage project budgets throughout the lifecycle.
• Align stakeholders and team members by setting clear expectations and maintaining a shared understanding of project goals.
• Identify, assess, monitor, and close project risks proactively.
• Manage scope, schedule, and cost changes using verification techniques to maintain an accurate and approved project plan.
• Improve team performance through leadership, mentoring, and motivation to foster cooperation.
• Measure and report project performance using appropriate tools and techniques.
• Ensure stakeholder alignment and manage resource prioritization.
• Escalate employee performance and workflow issues as needed.
• Review and spot-check deliverables to ensure quality and compliance.

Skills & Qualifications

• Minimum 5+ years of Project/Program Management experience in Quality Assurance within the medical device industry.
• Proven experience leading and managing projects focused on quality-based deliverables and initiatives.
• Minimum 10 years of overall professional experience in the medical-device industry required.
• Demonstrated success managing QA activities in M&A environments highly desired.
• Experience coordinating with RA and CA teams.
• PMP or equivalent certification preferred.
• Bachelor's Degree in Engineering.
• Proven ability to analyze and resolve complex process and system issues using independent judgment.
• Strong interpersonal, communication, and negotiation skills.
• Ability to build trust and influence mid-level management and present effectively to executives.
• Skilled in generating and explaining detailed proposals, schedules, budgets, and documentation.
• Proficient in project management tools and software.
• Medical device industry expertise with a deep understanding of FDA regulations, ISO standards, and global quality systems required.

Worksite Location, Job Type and Work Environment.

This is a fully onsite position in Irvine, CA. Program Manager is required to work onsite 5 days per week (Mon-Fri). This is a contract position. The work environment is dynamic and requires the use of various project management tools and Microsoft Project. The company offers paid time off and paid holidays.