Project Manager, Quality

Clinisys•Morrisville, NC

11d•$95,000 - $115,000•Hybrid

About The Position

Building an AI‑first organization is central to Clinisys’ purpose and the impact we deliver. As a global provider of intelligent diagnostic informatics solutions, we build AI‑enabled, cloud‑based platforms to enhance diagnostic workflows across healthcare, life sciences, and public health. By applying intelligent technology thoughtfully and responsibly, we help laboratories and testing environments operate more effectively, generate meaningful insights at scale, and ultimately support healthier and safer communities. Operating across more than 30 countries, Clinisys expects all colleagues—regardless of role or function—to work confidently with AI‑enabled tools, apply digital and analytical thinking, and continuously adapt as technologies evolve, must drive an AI first sense of purpose and urgency. The Project Manager, Quality is an individual contributor responsible for driving measurable improvements across Clinisys business processes by leveraging industry best practices, international regulatory insights and operational key performance indicators (KPIs). This role excels in being able to listen to customers’ needs and internal operations and recommend improvements to our processes that are client-centered, efficient and compliant. This role requires aptitude and comfort while managing multiple large projects simultaneously, developing rapport and working with a global team and product lines. The position operates within a matrix environment, collaborating with Quality, Regulatory, R&D, IT, Operations, and Customer-facing teams to implement sustainable improvements. This role is based in Raleigh, NC with a requirement to be on-site 3 days per week.

Requirements

Comfortable operating in a highly matrixed environment with multiple stakeholders and decision makers.
Knowledge in quality systems, IT, regulated healthcare, medical device, laboratory, or life sciences environments.
Comfortable applying AI and AI agents to enhance pattern recognition in metrics and continuous improvement applications.
Use AI to expedite the “identify, learn, and apply” cycle across all operations.
Experience in client management, clinical safety decision making, or complaints management.
Ability to apply project management skills to any of the above areas.
Willingness to learn AI concepts and applications relevant to project management.
Strong analytical and problem-solving capabilities.
Excellent written and verbal communication skills, with the ability to influence across functions and organizational levels.
High attention to detail combined with strategic perspective.
Proficiency with electronic QMS platforms, digital workflows, data analytics tools, and AI-enabled solutions.
Bachelor’s degree in science, IT, engineering, healthcare, or a related field.
4-7 years of experience in Quality within a regulated environment (medical device, diagnostics, software as a medical device, or life sciences preferred).
3–5 years of experience managing complicated projects or programs in a matrix or cross-functional environment.
Experience supporting or contributing to audits, CAPA, or process improvement initiatives.
Experience applying a recognized continuous improvement methodology, such as Lean, Six Sigma, Kaizen, Deming Cycle or equivalent, to deliver measurable process improvements.

Nice To Haves

PMP certification or equivalent project management training (preferred, but not required)
Experience in using LIMS (preferred, but not required)
Audit experience (preferred, but not required)
Lean Six Sigma Green Belt or Black Belt certification is preferred.
Experience across to full product lifecycle processes (design, development, post-market support and surveillance) is preferred.

Responsibilities

Plan and deliver cross-functional continuous improvement projects from initiation through execution and closure.
Coordinate stakeholders across global teams, ensuring alignment and timely delivery of objectives.
Use AI agents to ensure consistency of clinical safety analysis and improve issue resolutions.
Track milestones, risks, dependencies, and outcomes using structured project management methods.
Use AI agents to enhance process analysis, pattern detection, and prioritization of improvement opportunities.
Facilitate workshops, working groups, and improvement sessions with key stakeholders.
Analyze performance data, audit findings, and feedback to identify improvement opportunities. Use AI to expedite this identify, learn, and apply cycle across all operations.
Support the integration of improvements into controlled processes, procedures, and training materials.
Partner with diverse stakeholders to ensure compliance is maintained while timelines are met.
Assist stakeholders with assessing continuous improvement ideas, consolidating where possible, and constructing timelines and project plans to attain goal.
Comfortable presenting progress, elevation of issues and recommendations to senior management.
Accountable for delivering measurable improvements in key KPIs across the software development lifecycle, such as first pass acceptance, cycle time, complaints, supply chain and end of life efficiency.