Project Manager - Healthmark QMS, Defined Term (Remote in EST)

Job Overview

The Project Manager – Quality and Regulatory will lead and coordinate projects aimed at Quality Management System (QMS) enhancement initiatives. The project manager will serve as the primary driver of project(s) execution across a group of QMS workstreams, coordinating cross-functional teams and ensuring delivery against defined milestones. Key deliverables include the development of project timelines, project team assembly, managing the schedule and maintaining effective communication through the project. This position is defined term for approximately 12 months. While the role is remote, candidates should reside in Eastern Standard Time.

Job Responsibilities and Essential Duties:

• Serve as project manager, owning an integrated schedule, milestone tracking, and status reporting across all QMS workstreams.
• Apply formal PMI-based project management methodology including scope, schedule, risk, issue, and change management disciplines.
• Develop and maintain project-level RAID logs, status dashboards, and executive-level reporting cadence.
• Facilitate reviews and workstream-level working sessions with Quality, Regulatory, Operations, and cross-functional stakeholders.
• Lead project coordination across the following QMS enhancement areas: Product Development Process, Receiving Inspection, Complaints & Vigilance, Validation, Device History Records (DHRs), Inspection & In-Process Controls, Corrective and Preventive Action (CAPA), and Training.
• Support SOP development, gap closure documentation, and audit-readiness activities within scope.
• Develop and present structured status reports to project teams and senior leadership on a defined cadence.
• Escalate risk and issues proactively; recommend resolution paths with supporting analysis.
• Contribute to the ongoing development of PMO tools, templates, and governance processes within Healthmark’s program management function.
• Identify process improvement opportunities within the QMS implementation approach and recommend enhancements.
• Collaborate with Quality Assurance and Regulatory Affairs to ensure all project deliverables meet FDA 21 CFR Part 820 / QMSR and ISO 13485:2016 requirements.
• Proficiency in Microsoft Project and/or equivalent project scheduling tools (Smartsheet, Monday.com); strong Microsoft 365 skills (Teams, SharePoint, Excel).

Required Knowledge, Skills and Abilities:

• Expert-level working knowledge of FDA 21 CFR Part 820 / Quality Management System Regulation (QMSR), including its incorporation of ISO 13485:2016 effective February 2026.
• Strong applied understanding of ISO 13485:2016 QMS requirements throughout the device lifecycle.
• Demonstrated hands-on experience with the following QMS process areas: Product Development Process / Design Controls, Receiving Inspection, Complaints & Vigilance / MDR reporting, Validation (IQ/OQ/PQ), Device History Records, Inspection and In-Process Controls, CAPA, and Training.
• Familiarity with ISO 14971 risk management principles and FDA 510(k) / Class II submission processes is advantageous.
• Demonstrated experience leading complex, multi-workstream projects within a formal project management framework (PMI PMBOK preferred).
• Proven ability to develop and manage integrated project schedules, RAID logs, status reports, and steering committee materials.
• Experience managing cross-functional teams in a matrixed organizational environment without direct line authority.
• Excellent written and verbal communication skills; ability to present complex regulatory and project information clearly to both technical and executive audiences.
• Proven ability to influence, align, and lead cross-functional stakeholders without direct supervisory authority.
• Strong organizational skills; detail-oriented with a track record of delivering on schedule in regulated environments.

Minimum Requirements: 

• Bachelor’s degree in engineering, Life Sciences, Quality, Business Administration, or a related field required.
• Master’s degree or advanced technical credential a plus.
• Minimum 5 years of experience in project or program management roles within the medical device industry.
• Minimum 3 years of direct, hands-on experience implementing or managing QMS projects under FDA 21 CFR Part 820 and/or ISO 13485 in a regulated medical device environment.
• Experience in supporting or leading QMS projects for companies undergoing FDA Class I and/or Class II classification transitions or regulatory remediation projects is strongly preferred.
• PMP (Project Management Professional) certification is highly desired.

Quality Requirements: 

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

Environmental/Safety/Physical Work Conditions: 

• Primarily office/hybrid environment; use of computer, telephone, and related office accessories to complete assignments.
• May work extended hours during peak milestones or audit preparation cycles.
• Occasional domestic travel may be required (estimated up to 20-25% depending on site-based activities).
• Physical requirements: ability to sit/stand at a workstation for extended periods; occasional lifting up to 20 lbs.

The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.