Project Manager, Quality

Purpose

Clinisys builds AI-enabled, cloud-based platforms to enhance diagnostic workflows across healthcare, life sciences, and public health. The company aims to apply intelligent technology thoughtfully and responsibly to support healthier and safer communities.

About the role

The Project Manager, Quality is responsible for driving measurable improvements across Clinisys business processes by leveraging industry best practices, international regulatory insights, and operational key performance indicators (KPIs).

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.
• 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.
• Absorb and present progress, elevate issues, and make 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.

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.
• 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.
• 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).

Skills Needed

• 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.
• 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.
• 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).

Qualifications

• 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.
• Leverage Lean Six Sigma Green Belt or Black Belt certification (preferred).
• Experience across to full product lifecycle processes (design, development, post-market support and surveillance) is preferred.

Physical Requirements

• Hybrid work (minimum 3 days per week in office).
• Work performed in a normal office setting.
• Prolonged periods of sitting and computer use.
• Moderate lifting/carrying 15-44 lbs.; walking/standing 2-6 hours.

Benefits

Our benefits for Full Time employees are designed to help you move forward in your career, and in areas of your life outside of work. From health and wellness benefits, 401 (k) Savings Plan, stock incentive programs, paid time off, parental leave, and tuition assistance, we've got you covered with our total rewards package.

Pay

The starting pay range for a candidate selected for this position who is generally within the range of $95,000 - $115,000 for annual base salary. The successful candidate’s actual pay will be based on various factors, such as work location, qualifications, and experience, so the actual starting pay may be above or below this range.

Schedule

This role is based in Raleigh, NC with a requirement to be on-site 3 days per week.

Company Commitment to Equal Opportunity

Clinisys Information systems is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law.